Drug:
Reaction: DEVICE ISSUE
20250101 - 20251231
No. 901 - 1000
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 901 | 24964679 |
CA |
66 | 1 |
Cataract, Device infusion issue, Device issue, Diarrhoea, Incorrect drug administration rate, Injection site discharge, Medication error, Product use in unapproved indication, Wrong technique in product usage process, Off label use, |
||||
HUMAN IMMUNOGLOBULIN G, HUMAN IMMUNOGLOBULIN G, HUMAN IMMUNOGLOBULIN G, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, CALCIUM, CALCIUM, ERGOCALCIFEROL, INSULIN LISPRO, EMPAGLIFLOZIN, INSULIN GLARGINE, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, METOPROLOL TARTRATE, METOPROLOL, PANTOPRAZOLE SODIUM, PANTOPRAZOLE, PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE, PANTOPRAZOLE SODIUM INJECTION, PREDNISONE, PREGABALIN, ERGOCALCIFEROL, |
||||
| 902 | 24965163 |
US |
1 | |
Incorrect dose administered by device, Accidental exposure to product, Device issue, |
||||
ADALIMUMAB-ADAZ, ADALIMUMAB-ADAZ, |
||||
| 903 | 24965329 |
US |
33 | 1 |
Device issue, Product dose omission issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 904 | 24965574 |
CA |
68 | 1 |
Intentional product use issue, Intercepted product preparation error, Liquid product physical issue, Device issue, Syringe issue, Device issue, |
||||
LEUPROLIDE ACETATE, LEUPROLIDE ACETATE, LEUPROLIDE ACETATE, LEUPROLIDE ACETATE, |
||||
| 905 | 24965743 |
CL |
||
Device issue, |
||||
SOMATROPIN, |
||||
| 906 | 24965778 |
US |
15 | 1 |
Device issue, |
||||
SOMATROPIN, |
||||
| 907 | 24965869 |
US |
82 | 1 |
Intercepted product preparation error, Wrong technique in product usage process, Device issue, Syringe issue, Device leakage, |
||||
LEUPROLIDE ACETATE, LEUPROLIDE ACETATE, |
||||
| 908 | 24965994 |
IN |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 909 | 24966484 |
AE |
||
Device issue, Device leakage, Drug dose omission by device, |
||||
SOMATROGON-GHLA, |
||||
| 910 | 24966748 |
US |
1 | |
Abdominal pain, Device issue, |
||||
ADALIMUMAB, |
||||
| 911 | 24966838 |
JP |
1 | |
Product dose omission issue, Device issue, |
||||
GOLIMUMAB, |
||||
| 912 | 24966885 |
US |
14 | 1 |
Device use error, Device issue, Device breakage, |
||||
SOMATROPIN, |
||||
| 913 | 24966895 |
US |
17 | 1 |
Drug dose omission by device, Device issue, Device breakage, |
||||
SOMATROPIN, |
||||
| 914 | 24967011 |
US |
2 | |
Product dose omission issue, Product administered at inappropriate site, Patient dissatisfaction with device, Device issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 915 | 24967140 |
US |
59 | 1 |
Device issue, Product dose omission issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 916 | 24967204 |
US |
2 | |
Pulmonary tuberculosis, Intentional product misuse, Memory impairment, Fall, Tremor, Nasopharyngitis, Mental impairment, Device issue, Pulmonary pain, |
||||
CARBIDOPA AND LEVODOPA, CARBIDOPA AND LEVODOPA, CARBIDOPA AND LEVODOPA, |
||||
| 917 | 24967205 |
CH |
80 | 2 |
Herpes zoster, Gait inability, Back pain, Pain, Device issue, Fall, Freezing phenomenon, Product administration error, Off label use, On and off phenomenon, Abdominal pain, Erythema, Thoracic vertebral fracture, Electric shock sensation, Dysstasia, |
||||
| 918 | 24967231 |
US |
1 | |
Accidental exposure to product, Device issue, Product dose omission issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 919 | 24967321 |
GB |
65 | 2 |
Amnesia, Aspiration, Muscle rigidity, Nausea, Weight decreased, Dystonia, Tremor, Dyskinesia, Fall, Injury, Abnormal dreams, Cognitive disorder, Hiatus hernia, Gastritis, Duodenal ulcer, Duodenitis, Device issue, Device issue, Device occlusion, Device dislocation, Embedded device, |
||||
PROCHLORPERAZINE, FLUOXETINE HYDROCHLORIDE, FLUOXETINE, LANSOPRAZOLE, MIRTAZAPINE, SENNOSIDES, SENNA LEAF, SENNA, SENNOSIDES 8.6 MG TABLETS, |
||||
| 920 | 24957638 |
CA |
18 | 1 |
Device issue, Inappropriate schedule of product administration, |
||||
GOLIMUMAB, |
||||
| 921 | 24957653 |
ES |
77 | 1 |
Respiratory disorder, Wrong technique in device usage process, Device issue, Device dislocation, Increased bronchial secretion, Incorrect route of product administration, Pyrexia, Respiratory tract infection, Bronchitis chronic, Weight decreased, Bacterial infection, |
||||
| 922 | 24957705 |
US |
1 | |
Device issue, Drug ineffective, Asthenia, Off label use, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 923 | 24957755 |
PT |
||
Device issue, Product dose omission issue, |
||||
GOLIMUMAB, |
||||
| 924 | 24958067 |
DE |
||
Product dose omission issue, Device issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 925 | 24958568 |
US |
44 | 1 |
Crohn^s disease, Device issue, Device malfunction, Product dose omission issue, |
||||
USTEKINUMAB, USTEKINUMAB, PROMETHAZINE, PROMETHAZINE HYDROCHLORIDE, PANTOPRAZOLE, TRIMETHOPRIM, |
||||
| 926 | 24958610 |
US |
64 | 2 |
Crohn^s disease, Device issue, Needle issue, Accidental exposure to product, Product dose omission issue, Off label use, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 927 | 24958712 |
US |
||
Dyspnoea at rest, Device use issue, Incorrect dose administered, Drug dose omission by device, Wrong technique in device usage process, Wrong technique in product usage process, Device issue, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 928 | 24958867 |
US |
||
Drug dose omission by device, Device issue, Device delivery system issue, Device deposit issue, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 929 | 24959448 |
CA |
84 | 2 |
Cerebral haemorrhage, Device issue, Fall, Incorrect dose administered, Incorrect product administration duration, Lymphoma, Pneumonia, Off label use, |
||||
HUMAN IMMUNOGLOBULIN G, APIXABAN, IBRUTINIB, HUMAN IMMUNOGLOBULIN G, METOPROLOL TARTRATE, METOPROLOL, |
||||
| 930 | 24959661 |
FR |
79 | 1 |
Intercepted product administration error, Device issue, |
||||
LEUPROLIDE ACETATE, |
||||
| 931 | 24960818 |
US |
1 | |
Circumstance or information capable of leading to device use error, Device issue, |
||||
ADALIMUMAB-ADAZ, |
||||
| 932 | 24961166 |
GB |
8 | 2 |
Lower respiratory tract infection, Device issue, Localised infection, Oral herpes, Tinea pedis, |
||||
USTEKINUMAB, |
||||
| 933 | 24961525 |
US |
||
Drug dose omission by device, Wrong technique in product usage process, Circumstance or information capable of leading to device use error, Device issue, No adverse event, |
||||
ALBUTEROL SULFATE, SERTRALINE, BUPROPION HYDROCHLORIDE, BUPROPION, |
||||
| 934 | 24961825 |
JP |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 935 | 24961906 |
US |
14 | 1 |
Device issue, Drug dose omission by device, |
||||
SOMATROPIN, SERTRALINE HYDROCHLORIDE, SERTRALINE, |
||||
| 936 | 24961985 |
JP |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 937 | 24962022 |
US |
92 | 1 |
Injection site pain, Device issue, |
||||
| 938 | 24962577 |
DE |
2 | |
Fall, Musculoskeletal stiffness, Gait inability, Malaise, Gait disturbance, Aphasia, Device issue, Mobility decreased, Unintentional medical device removal, |
||||
| 939 | 24952766 |
CA |
59 | 2 |
Alanine aminotransferase increased, Allergic sinusitis, Antinuclear antibody positive, Arthralgia, Arthritis, Arthropathy, Blood iron decreased, Blood uric acid increased, C-reactive protein increased, Condition aggravated, Cyst, Hepatic enzyme increased, Injection site pain, Injection site warmth, Joint effusion, Joint swelling, Nephrolithiasis, Oedema, Osteoarthritis, Pain, Pain in extremity, Psoriasis, Pyrexia, Rash, Renal disorder, Sepsis, Synovial disorder, Synovitis, Tendonitis, Urinary tract infection, Vitamin B12 decreased, Incorrect dose administered, Drug ineffective, Device issue, Wrong technique in device usage process, |
||||
DULOXETINE HYDROCHLORIDE, DULOXETINE, INDOMETHACIN, INDOMETHACIN, INDOMETHACIN, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, BISOPROLOL FUMARATE, BISOPROLOL FUMARATE, BISOPROLOL FUMARATE, DULOXETINE HYDROCHLORIDE, DULOXETIN HYDROCHLORIDE, DULOXETINE, DULOXETINE HYDROCHLORIDE, DULOXETIN HYDROCHLORIDE, DULOXETINE, DULOXETINE HYDROCHLORIDE, DULOXETIN HYDROCHLORIDE, DULOXETINE, FOLIC ACID, FOLIC ACID, FOLIC ACID, INDOMETHACIN, INDOMETHACIN, INDOMETHACIN, EMPAGLIFLOZIN, EMPAGLIFLOZIN, EMPAGLIFLOZIN, LEFLUNOMIDE, LEFLUNOMIDE, LEFLUNOMIDE, ALLOPURINOL, ALLOPURINOL, ALLOPURINOL, CELECOXIB, CELECOXIB, CELECOXIB, CELECOXIB, CYANOCOBALAMIN, CYANOCOBALAMIN, CYANOCOBALAMIN, DICLOFENAC, DICLOFENAC SODIUM, DICLOFENAC, DICLOFENAC SODIUM, DICLOFENAC, DICLOFENAC SODIUM, IBUPROFEN, IBUPROFEN CAPSULES 200 MG, IBUPROFEN TABLETS USP, 200MG, IBUPROFEN ORAL, IBUPROFEN 200MG, IBUPFROFEN, IBUPROFEN TABLET, FILM-COATED, IBUPROFEN 200 MG, IBUPROFEN CAPSULE, IBUPROFEN, IBUPROFEN CAPSULES 200 MG, IBUPROFEN TABLETS USP, 200MG, IBUPROFEN ORAL, IBUPROFEN 200MG, IBUPFROFEN, IBUPROFEN TABLET, FILM-COATED, IBUPROFEN 200 MG, IBUPROFEN CAPSULE, IBUPROFEN, IBUPROFEN CAPSULES 200 MG, IBUPROFEN TABLETS USP, 200MG, IBUPROFEN ORAL, IBUPROFEN 200MG, IBUPFROFEN, IBUPROFEN TABLET, FILM-COATED, IBUPROFEN 200 MG, IBUPROFEN CAPSULE, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, NAPROXEN, NAPROXEN SODIUM, NAPROXEN, NAPROXEN SODIUM, NAPROXEN, NAPROXEN SODIUM, PANTOPRAZOLE SODIUM, PANTOPRAZOLE, PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE, PANTOPRAZOLE SODIUM INJECTION, PANTOPRAZOLE SODIUM, PANTOPRAZOLE, PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE, PANTOPRAZOLE SODIUM INJECTION, PANTOPRAZOLE SODIUM, PANTOPRAZOLE, PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE, PANTOPRAZOLE SODIUM INJECTION, PANTOPRAZOLE SODIUM, PANTOPRAZOLE, PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE, PANTOPRAZOLE SODIUM INJECTION, PANTOPRAZOLE SODIUM, PANTOPRAZOLE, PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE, PANTOPRAZOLE SODIUM INJECTION, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE, EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE, EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE, EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE, EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE, EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE, |
||||
| 940 | 24952767 |
US |
35 | 1 |
Product dose omission issue, Device issue, Accidental exposure to product, Device malfunction, Psoriasis, |
||||
GUSELKUMAB, |
||||
| 941 | 24953004 |
US |
24 | 2 |
Product dose omission issue, Device issue, Abdominal distension, Ecchymosis, Off label use, |
||||
USTEKINUMAB, USTEKINUMAB, LISDEXAMFETAMINE DIMESYLATE, METOPROLOL SUCCINATE, MERCAPTOPURINE, ONABOTULINUMTOXINA, HYDROCODONE BITARTRATE, CLONAZEPAM, ZOLPIDEM TARTRATE, PANTOPRAZOLE SODIUM, ERGOCALCIFEROL, IRON, RIZATRIPTAN BENZOATE, IPRATROPIUM BROMIDE, ESKETAMINE HYDROCHLORIDE, ALBUTEROL SULFATE, ALBUTEROL, BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, SPIRONOLACTONE, FLUVOXAMINE MALEATE, ATOGEPANT, ARIPIPRAZOLE, |
||||
| 942 | 24953356 |
US |
2 | |
Nausea, Incorrect dose administered by device, Device issue, |
||||
TERIPARATIDE, |
||||
| 943 | 24953616 |
US |
57 | |
Product dose omission issue, Device issue, Product leakage, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 944 | 24953705 |
US |
77 | 2 |
Blood glucose increased, Drug dose omission by device, Device issue, Wrong technique in device usage process, |
||||
INSULIN GLARGINE, |
||||
| 945 | 24953777 |
NL |
76 | 2 |
Cataract, Embedded device, Abnormal dreams, Hallucination, visual, Freezing phenomenon, Restlessness, Musculoskeletal stiffness, Hyperkinesia, Memory impairment, Disturbance in attention, Stoma site irritation, Stoma site discharge, Device issue, Obsessive-compulsive disorder, |
||||
PRAMIPEXOLE, |
||||
| 946 | 24954199 |
NL |
82 | 2 |
Breast cancer recurrent, Abnormal faeces, Memory impairment, Hallucination, Device issue, Dyskinesia, Device occlusion, Restlessness, |
||||
| 947 | 24954308 |
AR |
2 | |
Arthritis, Muscle contracture, Device issue, Product dose omission issue, |
||||
GOLIMUMAB, |
||||
| 948 | 24955122 |
US |
2 | |
Device issue, No adverse event, Product dose omission issue, |
||||
TOCILIZUMAB, PREDNISONE, ALENDRONATE SODIUM, ALENDRONATE SODIUM TABLET, ALENDRONATE SODIUM, ALENDRONATE SODIUM TABLET, ALENDRONATE SODIUM, ALENDRONATE SODIUM TABLET, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, |
||||
| 949 | 24955204 |
US |
||
Pruritus, Device issue, |
||||
ESTRADIOL, ESTRADIOL, ESTRADIOL, |
||||
| 950 | 24955233 |
DE |
||
Device issue, |
||||
GUSELKUMAB, GUSELKUMAB, |
||||
| 951 | 24955425 |
US |
23 | 2 |
Device malfunction, Accidental exposure to product, Device issue, Drug dose omission by device, |
||||
SECUKINUMAB, MAGNESIUM, ZINC, ZINC GLUCONATE, ZINC CHLORIDE, FISH OIL, ERGOCALCIFEROL, IRON, ESCITALOPRAM, |
||||
| 952 | 24955735 |
US |
2 | |
Limb injury, Psoriasis, Device issue, Incorrect dose administered, |
||||
RISANKIZUMAB-RZAA, |
||||
| 953 | 24955844 |
US |
8 | 2 |
Device issue, |
||||
SOMATROPIN, |
||||
| 954 | 24956122 |
KR |
6 | 1 |
Vomiting, Nausea, Abdominal pain upper, Device delivery system issue, Device issue, Device leakage, |
||||
SOMATROPIN, |
||||
| 955 | 24956128 |
AR |
3 | 1 |
Device power source issue, Device information output issue, Device issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 956 | 24956142 |
US |
8 | 1 |
Device defective, Device issue, Device use issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 957 | 24956153 |
US |
13 | 2 |
Device issue, Wrong technique in device usage process, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 958 | 24956203 |
AR |
12 | 1 |
Device issue, Poor quality device used, Device leakage, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 959 | 24956283 |
JP |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 960 | 24956319 |
KR |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 961 | 24956332 |
CH |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 962 | 24956366 |
US |
2 | |
Device issue, Drug dose omission by device, Accidental exposure to product, Condition aggravated, Device malfunction, |
||||
OFATUMUMAB, OFATUMUMAB, |
||||
| 963 | 24956450 |
US |
20 | 1 |
Injection site swelling, Injection site irritation, Injection site pain, Incorrect dose administered, Device issue, |
||||
ADALIMUMAB, KETOCONAZOLE, KETOCONAZOLE FOAM, KETOCONAZOLE CREAM, 2%, |
||||
| 964 | 24956736 |
US |
||
Colon cancer, Device malfunction, Device issue, Device use issue, Incorrect dose administered by device, Wrong technique in product usage process, |
||||
| 965 | 24956881 |
US |
19 | 1 |
Seizure, Musculoskeletal disorder, Haematochezia, Hemiplegia, Device issue, Feeding disorder, Gait inability, Cerebrovascular accident, Arterial injury, Procedural complication, Seizure, |
||||
ADALIMUMAB, ADALIMUMAB, LAMOTRIGINE, LORAZEPAM, PRUCALOPRIDE, LUBIPROSTONE, LACOSAMIDE, CLOBAZAM, |
||||
| 966 | 24957097 |
US |
||
Product dose omission issue, Cough, No adverse event, Device issue, Incorrect dose administered, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 967 | 24957279 |
CA |
57 | 1 |
Contusion, Influenza, Nasopharyngitis, Therapeutic procedure, Device issue, Off label use, |
||||
HUMAN IMMUNOGLOBULIN G, HUMAN IMMUNOGLOBULIN G, FOLIC ACID, PYRIDOSTIGMINE BROMIDE, METHOTREXATE, METHOTREXATE SODIUM, PREDNISONE, |
||||
| 968 | 24957334 |
GR |
31 | 1 |
Pneumonia, Accidental exposure to product, Incorrect dose administered, Device issue, |
||||
BIMEKIZUMAB, |
||||
| 969 | 24957348 |
US |
2 | |
General anaesthesia, Orthopaedic procedure, Device dislocation, Device placement issue, Device issue, Device deployment issue, Complication of device insertion, Complication associated with device, Complication of device removal, Incorrect product administration duration, No adverse event, |
||||
ETONOGESTREL, |
||||
| 970 | 24946337 |
US |
||
Device issue, Product dose omission issue, |
||||
FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, |
||||
| 971 | 24946575 |
US |
71 | |
Product dose omission issue, Wrong technique in product usage process, Device defective, Device issue, No adverse event, |
||||
TOCILIZUMAB, |
||||
| 972 | 24946606 |
US |
40 | 2 |
Vomiting, Device issue, Abdominal pain upper, Nausea, Dizziness postural, Abdominal discomfort, Haematochezia, Haematemesis, |
||||
RISANKIZUMAB-RZAA, |
||||
| 973 | 24946638 |
BR |
828 | 2 |
Blood glucose increased, Device issue, Device leakage, Device failure, Wrong technique in product usage process, |
||||
INSULIN ASPART INJECTION, INSULIN ASPART, INSULIN ASPART INJECTION, INSULIN ASPART, |
||||
| 974 | 24946806 |
US |
39 | 1 |
Product dose omission issue, Device malfunction, No adverse event, Device issue, Wrong technique in device usage process, |
||||
OMALIZUMAB, |
||||
| 975 | 24947192 |
US |
62 | |
Injection site pain, Injection site haemorrhage, Fear of injection, Product dose omission issue, Device issue, Device use issue, Insurance issue, |
||||
EXENATIDE, |
||||
| 976 | 24947918 |
US |
62 | 1 |
Wrong technique in product usage process, Device occlusion, Device issue, |
||||
CARBIDOPA AND LEVODOPA, CARBIDOPA AND LEVODOPA, |
||||
| 977 | 24948224 |
US |
29 | 2 |
Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Embedded device, Emotional disorder, Device material issue, Device issue, Device dislocation, |
||||
COPPER, |
||||
| 978 | 24948342 |
US |
1 | |
Accidental exposure to product, Device issue, |
||||
SECUKINUMAB, |
||||
| 979 | 24948711 |
US |
69 | 2 |
Off label use, Device issue, Accidental exposure to product, Product quality issue, Bladder disorder, Inappropriate schedule of product administration, |
||||
TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, |
||||
| 980 | 24949017 |
GR |
2 | |
Drug dose omission by device, Inappropriate schedule of product administration, Device issue, |
||||
SOMATROPIN, |
||||
| 981 | 24949698 |
US |
27 | 2 |
Device defective, Product dose omission issue, Device issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 982 | 24950093 |
US |
45 | 2 |
Device issue, Product dose omission issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 983 | 24950525 |
DE |
51 | 2 |
Heavy menstrual bleeding, Device dislocation, Menstruation irregular, Uterine polyp, Dysmenorrhoea, Device issue, Complication associated with device, Product use issue, Contraindicated product administered, |
||||
ETONOGESTREL, PROGESTERONE, CANDESARTAN, BISOPROLOL FUMARATE, PANTOPRAZOLE, |
||||
| 984 | 24950568 |
US |
1 | |
Hospitalisation, Parkinson^s disease, Tremor, Surgery, Stoma site discharge, Hypotension, Device leakage, Therapeutic response shortened, Loss of personal independence in daily activities, Loss of consciousness, Fatigue, Insomnia, Incorrect dose administered, Device issue, Device breakage, |
||||
CARBIDOPA AND LEVODOPA, CARBIDOPA AND LEVODOPA, |
||||
| 985 | 24951011 |
US |
9 | 2 |
Drug dose omission by device, Device issue, |
||||
SOMATROPIN, |
||||
| 986 | 24951094 |
US |
15 | 1 |
Device issue, |
||||
SOMATROPIN, |
||||
| 987 | 24951383 |
CN |
||
Device issue, |
||||
GUSELKUMAB, |
||||
| 988 | 24951943 |
US |
47 | 2 |
Rheumatoid arthritis, Injection site mass, Limb discomfort, Insomnia, Injection site erosion, Wrong technique in product usage process, Drug ineffective, Device issue, |
||||
CERTOLIZUMAB PEGOL, CERTOLIZUMAB PEGOL, |
||||
| 989 | 24952208 |
US |
12 | 2 |
Drug ineffective, Device issue, Drug dose omission by device, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 990 | 24952422 |
US |
35 | 2 |
Device issue, Product dose omission issue, Off label use, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 991 | 24952426 |
CN |
||
Hypoxia, Device issue, Drug dose omission by device, Wrong technique in product usage process, Incorrect dose administered by device, Lung disorder, |
||||
| 992 | 24961673 |
|||
Device issue, Device alarm issue, |
||||
NOREPINEPHRINE (BITARTRATE), NOREPINEPHRINE, NOREPINEPHRINE BITARTRATE, |
||||
| 993 | 24944538 |
US |
2 | |
Accidental exposure to product, Exposure via eye contact, Incorrect dose administered by device, Needle issue, Device issue, |
||||
GLATIRAMER ACETATE, |
||||
| 994 | 24944540 |
US |
30 | 1 |
Crohn^s disease, Device issue, Gastrointestinal pain, Gastrointestinal pain, Haematochezia, Drug level decreased, Crohn^s disease, |
||||
ADALIMUMAB, ADALIMUMAB, |
||||
| 995 | 24944820 |
US |
1 | |
Incorrect dose administered, Device issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 996 | 24944896 |
US |
17 | 2 |
Needle issue, Device issue, Product complaint, Device defective, Product dose omission issue, No adverse event, |
||||
OMALIZUMAB, OMALIZUMAB, |
||||
| 997 | 24945100 |
US |
||
Accidental exposure to product, Occupational exposure to product, Device issue, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, |
||||
| 998 | 24939718 |
CH |
80 | 1 |
Loss of personal independence in daily activities, Muscle spasms, Off label use, Lethargy, Device issue, Product dispensing error, Motor dysfunction, Hyperkinesia, Dyskinesia, Incontinence, Device issue, Freezing phenomenon, |
||||
TRAZODONE HYDROCHLORIDE, |
||||
| 999 | 24940116 |
US |
60 | 1 |
Infusion site infection, Infusion site pain, Infusion site discharge, Headache, Nausea, Infusion site erythema, Infusion site swelling, Dyspnoea, Decreased appetite, Diarrhoea, Fatigue, Peripheral swelling, Device dislocation, Device power source issue, Device issue, Device wireless communication issue, Electromagnetic interference, Device temperature issue, Device computer issue, |
||||
TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATED, FAMOTIDINE, FOLIC ACID, THIAMINE HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE, PANTOPRAZOLE SODIUM, KETAMINE HYDROCHLORIDE, ALBUTEROL SULFATE, APIXABAN, SILDENAFIL CITRATE, SILDENAFIL, SILDENAFIL POWDER,, FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE, CLONIDINE, KETOPROFEN, OXYGEN, 0XYGEN, SPIRONOLACTONE, LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE ANHYDROUS, CETIRIZINE HCL, CETIRIZINE, AMITRIPTYLINE HYDROCHLORIDE, GABAPENTIN, ONDANSETRON HYDROCHLORIDE, TORSEMIDE, |
||||
| 1000 | 24940263 |
GR |
8 | 1 |
Drug dose omission by device, Device issue, Product label issue, |
||||
SOMATROPIN, |
||||
disclaimer
Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
terms
license
last_updated
2025-04-28