Drug:
Reaction: DEVICE ISSUE
20250101 - 20251231
No. 1001 - 1100
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 1001 | 24940374 |
US |
77 | 2 |
Device issue, Device defective, Panic disorder, Product dose omission issue, Psoriasis, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 1002 | 24941196 |
US |
45 | 2 |
Crohn^s disease, Device issue, Product leakage, Underdose, Nasopharyngitis, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 1003 | 24941316 |
US |
2 | |
Grip strength decreased, Device issue, |
||||
CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, |
||||
| 1004 | 24941513 |
US |
84 | 1 |
Off label use, Circumstance or information capable of leading to medication error, Device issue, Product complaint, No adverse event, |
||||
FARICIMAB, FARICIMAB, FARICIMAB, FARICIMAB, |
||||
| 1005 | 24941746 |
JP |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 1006 | 24941942 |
US |
48 | 2 |
Colitis ulcerative, Underdose, Injection site haemorrhage, Injection site bruising, Device issue, Arthritis, |
||||
GOLIMUMAB, GOLIMUMAB, |
||||
| 1007 | 24941987 |
US |
39 | 1 |
Device malfunction, Injection site discharge, Incorrect dose administered by device, Device issue, |
||||
SECUKINUMAB, AMLODIPINE, TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE OINTMENT USP, 0.05%, |
||||
| 1008 | 24942198 |
US |
11 | 2 |
Device breakage, Device mechanical issue, Device issue, Drug dose omission by device, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 1009 | 24942199 |
US |
16 | 1 |
Device material issue, Device issue, |
||||
SOMATROPIN, |
||||
| 1010 | 24942220 |
US |
16 | 1 |
Drug dose omission by device, Product prescribing error, Device mechanical issue, Device issue, Device breakage, Poor quality device used, |
||||
SOMATROPIN, |
||||
| 1011 | 24942233 |
US |
||
Device issue, |
||||
CONJUGATED ESTROGENS, ESTROGENS, CONJUGATED, |
||||
| 1012 | 24942443 |
DE |
72 | 2 |
Parkinson^s disease, Dizziness, Device use error, Device issue, Gait inability, Drug ineffective, Akinesia, Dyskinesia, Hyperkinesia, On and off phenomenon, Hallucination, General physical health deterioration, Chills, Syncope, Motor dysfunction, |
||||
FOSCARBIDOPA/FOSLEVODOPA, FOSCARBIDOPA/FOSLEVODOPA, FOSCARBIDOPA/FOSLEVODOPA, |
||||
| 1013 | 24942677 |
US |
65 | 2 |
Blood glucose increased, Drug dose omission by device, Device issue, |
||||
INSULIN GLARGINE, |
||||
| 1014 | 24942695 |
US |
81 | 1 |
Blood glucose increased, Device issue, |
||||
INSULIN GLARGINE, |
||||
| 1015 | 24942824 |
US |
70 | 1 |
Injection site pain, Device issue, Device use issue, |
||||
INSULIN GLARGINE, |
||||
| 1016 | 24942857 |
US |
73 | 2 |
Tendonitis, Pain in extremity, Injection site haemorrhage, Needle issue, Device issue, |
||||
INSULIN GLARGINE, DULAGLUTIDE, |
||||
| 1017 | 24942960 |
JP |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 1018 | 24943036 |
US |
26 | 2 |
Abortion spontaneous, Hysterectomy, Cervical dysplasia, Device breakage, Foreign body in reproductive tract, Complication of device removal, Embedded device, Device issue, Emotional disorder, |
||||
COPPER, |
||||
| 1019 | 24943090 |
US |
2 | |
Incorrect dose administered by device, Device issue, Device deployment issue, |
||||
ADALIMUMAB-ADAZ, ADALIMUMAB-ADAZ, |
||||
| 1020 | 24943093 |
AR |
54 | 2 |
Psoriatic arthropathy, Anxiety, Device issue, Accidental exposure to product, Product dose omission issue, |
||||
GOLIMUMAB, GOLIMUMAB, METHOTREXATE, METHOTREXATE SODIUM, FOLIC ACID, |
||||
| 1021 | 24943122 |
JP |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 1022 | 24956872 |
64 | 2 | |
Blood glucose decreased, Fall, Head injury, Device issue, Anxiety, Nerve injury, |
||||
SERTRALINE, INSULIN HUMAN, ERGOCALCIFEROL, |
||||
| 1023 | 24933200 |
AU |
74 | 1 |
Liver abscess, Device issue, |
||||
| 1024 | 24934388 |
EG |
697 | 2 |
Diabetic ketoacidosis, Dizziness, Hyperglycaemia, Incorrect dose administered by device, Device issue, Wrong technique in product usage process, |
||||
PANTOPRAZOLE SODIUM, PANTOPRAZOLE, PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE, PANTOPRAZOLE SODIUM INJECTION, |
||||
| 1025 | 24934897 |
US |
51 | 1 |
Pulmonary fibrosis, Pulmonary hypertension, Hypoxia, Device issue, Decreased activity, |
||||
TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, TADALAFIL, OXYGEN, 0XYGEN, OXYGEN, 0XYGEN, OXYGEN, 0XYGEN, |
||||
| 1026 | 24934945 |
US |
||
Device issue, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, |
||||
| 1027 | 24934978 |
US |
35 | 1 |
Device issue, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, |
||||
| 1028 | 24934979 |
US |
66 | 2 |
Device delivery system issue, Device issue, Wrong technique in device usage process, |
||||
ABATACEPT, TORSEMIDE, MONTELUKAST SODIUM, PANTOPRAZOLE SODIUM, PANTOPRAZOLE, PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE, PANTOPRAZOLE SODIUM INJECTION, AZELASTINE, |
||||
| 1029 | 24935004 |
US |
70 | 2 |
Adverse event, Product dose omission issue, Device deployment issue, Device defective, Device issue, |
||||
USTEKINUMAB, USTEKINUMAB, USTEKINUMAB, USTEKINUMAB, |
||||
| 1030 | 24935163 |
US |
2 | |
Product dose omission issue, Device issue, |
||||
GLATIRAMER ACETATE, |
||||
| 1031 | 24935205 |
PR |
52 | 2 |
Device delivery system issue, Device issue, Device safety feature issue, |
||||
ABATACEPT, |
||||
| 1032 | 24935436 |
US |
65 | 1 |
Oxygen saturation decreased, Device maintenance issue, Device issue, Device issue, Device issue, |
||||
TREPROSTINIL, TREPROSTINIL, TIOTROPIUM BROMIDE, TESTOSTERONE CYPIONATE, SODIUM CHLORIDE, SODIUM CHLORIDE INJECTION, SODIUM CHLORIDE TABLET, NORMAL SALT TABLETS, AZELASTINE HYDROCHLORIDE, AZELASTINE, ATORVASTATIN CALCIUM, ALLOPURINOL, ALBUTEROL SULFATE, SILDENAFIL CITRATE, SILDENAFIL, SILDENAFIL POWDER,, BUPROPION HYDROCHLORIDE, VITAMIN C, MACITENTAN, MONTELUKAST SODIUM, MONTELUKAST, OXYGEN, 0XYGEN, OMEPRAZOLE, FAMOTODINE, ESOMEPRAZOLE MAGNESIUM, FAMOTIDINE, RANITIDINE HYDROCHLORIDE, GABAPENTIN, CETIRIZINE HYDROCHLORIDE, BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, TORSEMIDE, |
||||
| 1033 | 24935474 |
US |
76 | 1 |
Infusion site erythema, Infusion site pain, Pain, Epistaxis, Haemorrhoids, Infusion site discomfort, Frequent bowel movements, Dysuria, Peripheral swelling, Device issue, Device occlusion, Anal incontinence, |
||||
TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, TORSEMIDE, TAMSULOSIN HYDROCHLORIDE, SULFAMETHOXAZOLE AND TRIMETHOPRIM, SODIUM CHLORIDE, SODIUM CHLORIDE INJECTION, SODIUM CHLORIDE TABLET, NORMAL SALT TABLETS, LORAZEPAM, EMPAGLIFLOZIN, MAGNESIUM OXIDE, FINASTERIDE, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATED, METOPROLOL SUCCINATE, METOPROLOL SUCCINATE ER TABLETS, PREDNISONE, DIGOXIN, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, KETAMINE HYDROCHLORIDE, KETOPROFEN, LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE ANHYDROUS, AMITRIPTYLINE HYDROCHLORIDE, GABAPENTIN, CLONIDINE, MACITENTAN, |
||||
| 1034 | 24935575 |
US |
1 | |
Product dose omission issue, Product delivery mechanism issue, Device issue, |
||||
ALBUTEROL SULFATE, |
||||
| 1035 | 24937067 |
US |
14 | 1 |
Drug dose omission by device, Device mechanical issue, Device issue, Device material issue, |
||||
SOMATROPIN, |
||||
| 1036 | 24937070 |
US |
9 | 2 |
Drug dose omission by device, Device issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 1037 | 24937477 |
NZ |
63 | 2 |
Device issue, Device leakage, Contrast media reaction, Paraesthesia oral, Lip swelling, Lip blister, Rash, |
||||
IOHEXOL, |
||||
| 1038 | 24937649 |
IL |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 1039 | 24937880 |
TR |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 1040 | 24937944 |
TR |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 1041 | 24937976 |
BR |
||
Device issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 1042 | 24938149 |
EE |
||
Device issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 1043 | 24938172 |
US |
2 | |
Device issue, Drug administered in wrong device, Product knowledge deficit, |
||||
GLATIRAMER ACETATE, GLATIRAMER ACETATE, |
||||
| 1044 | 24938174 |
US |
2 | |
Incorrect dose administered by device, Device delivery system issue, Device issue, |
||||
ALBUTEROL SULFATE, |
||||
| 1045 | 24938226 |
US |
2 | |
Drug dose omission by device, Device issue, |
||||
ALBUTEROL SULFATE, |
||||
| 1046 | 24938227 |
US |
2 | |
Drug ineffective, Device issue, |
||||
ESTRADIOL, ESTRADIOL GEL 0.1%, ESTRADIOL TRANSDERMAL, ESTRADIOL,, ESTRADIOL, ESTRADIOL GEL 0.1%, ESTRADIOL TRANSDERMAL, ESTRADIOL,, PROGESTERONE, |
||||
| 1047 | 24939185 |
US |
32 | 1 |
Needle track marks, Device issue, Incorrect dose administered, Product dose omission issue, |
||||
BIMEKIZUMAB, |
||||
| 1048 | 24939244 |
US |
17 | 2 |
Product dose omission issue, Device issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 1049 | 24939258 |
US |
55 | 2 |
Device issue, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, |
||||
| 1050 | 24939452 |
US |
75 | 2 |
Device issue, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, |
||||
| 1051 | 24939477 |
US |
50 | 2 |
Product dose omission issue, Device use error, Device issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 1052 | 24925796 |
US |
||
Accidental exposure to product, Occupational exposure to product, Device issue, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, |
||||
| 1053 | 24926248 |
US |
36 | 2 |
Underdose, Device issue, |
||||
ESKETAMINE HYDROCHLORIDE, GABAPENTIN, CLONAZEPAM, CLONIDINE, CARIPRAZINE, DESVENLAFAXINE SUCCINATE, |
||||
| 1054 | 24926294 |
FR |
||
Device issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 1055 | 24927145 |
FR |
19 | 1 |
Product dose omission issue, Device issue, Off label use, |
||||
GOLIMUMAB, |
||||
| 1056 | 24927312 |
US |
50 | 2 |
Dysgeusia, Circumstance or information capable of leading to medication error, Device issue, |
||||
ADALIMUMAB-ADAZ, ADALIMUMAB-ADAZ, |
||||
| 1057 | 24928280 |
JP |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 1058 | 24928419 |
US |
72 | 2 |
Device issue, Intercepted product preparation error, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, CYCLOPHOSPHAMIDE FOR INJECTION, CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE INJECTION, SOLUTION, |
||||
| 1059 | 24928487 |
FR |
||
Device defective, Device issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 1060 | 24928737 |
US |
||
Device issue, |
||||
NITRIC OXIDE, |
||||
| 1061 | 24928738 |
US |
||
Device issue, |
||||
NITRIC OXIDE, |
||||
| 1062 | 24928746 |
US |
||
Device issue, |
||||
NITRIC OXIDE, |
||||
| 1063 | 24928747 |
US |
||
Device issue, |
||||
NITRIC OXIDE, |
||||
| 1064 | 24929036 |
FR |
66 | 1 |
Intercepted product preparation error, Device issue, Device occlusion, Syringe issue, |
||||
LEUPROLIDE ACETATE, |
||||
| 1065 | 24929930 |
JP |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 1066 | 24930014 |
US |
2 | |
Fatigue, Device issue, Swelling, Pain, Incorrect dose administered, |
||||
ADALIMUMAB, |
||||
| 1067 | 24930023 |
US |
18 | 1 |
Drug dose omission by device, Device issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 1068 | 24930147 |
US |
74 | 2 |
Tremor, On and off phenomenon, Dizziness, Fatigue, Device issue, |
||||
FOSCARBIDOPA/FOSLEVODOPA, |
||||
| 1069 | 24931796 |
US |
65 | 1 |
Surgery, Stoma site pain, Stoma complication, Device issue, |
||||
CARBIDOPA AND LEVODOPA, CARBIDOPA AND LEVODOPA, CARBIDOPA LEVODOPA, DONEPEZIL HYDROCHLORIDE, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GABAPENTIN, MELATONIN, ERGOCALCIFEROL, |
||||
| 1070 | 24932831 |
GB |
78 | 2 |
Device issue, Infection, |
||||
GOLIMUMAB, |
||||
| 1071 | 24919025 |
AR |
2 | |
Rheumatoid arthritis, Depression, Device issue, |
||||
GOLIMUMAB, |
||||
| 1072 | 24919089 |
IT |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 1073 | 24919417 |
US |
17 | 1 |
Off label use, Device issue, |
||||
| 1074 | 24920050 |
US |
60 | |
Aphonia, Device issue, Device delivery system issue, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 1075 | 24920694 |
US |
||
Drug dose omission by device, Wrong technique in product usage process, Device issue, Off label use, No adverse event, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 1076 | 24920844 |
US |
||
Device issue, |
||||
| 1077 | 24920901 |
US |
69 | |
Device malfunction, Device issue, |
||||
EXENATIDE, |
||||
| 1078 | 24920936 |
US |
||
Device issue, |
||||
NITRIC OXIDE, |
||||
| 1079 | 24920939 |
US |
63 | 2 |
Therapeutic product effect incomplete, Device issue, |
||||
ALBUTEROL SULFATE, |
||||
| 1080 | 24921296 |
US |
1 | |
Circumstance or information capable of leading to device use error, Device issue, |
||||
ALBUTEROL SULFATE, |
||||
| 1081 | 24921513 |
CN |
1 | |
Accidental exposure to product, Device issue, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
| 1082 | 24921700 |
US |
12 | 1 |
Device issue, Device mechanical issue, Device deployment issue, |
||||
SOMATROPIN, |
||||
| 1083 | 24921743 |
CH |
||
Device connection issue, Device leakage, Device occlusion, Device issue, |
||||
| 1084 | 24921762 |
TR |
||
Product dose omission issue, Device issue, |
||||
GOLIMUMAB, |
||||
| 1085 | 24921939 |
US |
2 | |
Device issue, Exposure via skin contact, No adverse event, Accidental exposure to product, |
||||
OMALIZUMAB, |
||||
| 1086 | 24921980 |
US |
49 | 2 |
Device issue, Product dose omission issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 1087 | 24922133 |
US |
75 | 2 |
Product dose omission issue, Device issue, |
||||
GUSELKUMAB, |
||||
| 1088 | 24922466 |
US |
15 | 1 |
Device issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 1089 | 24922502 |
US |
2 | |
Incorrect dose administered by device, Device issue, Device leakage, |
||||
SECUKINUMAB, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, |
||||
| 1090 | 24922799 |
US |
2 | |
Device issue, Device leakage, Product dose omission issue, Product administration error, |
||||
USTEKINUMAB, USTEKINUMAB, ONABOTULINUMTOXINA, |
||||
| 1091 | 24923137 |
KR |
||
Device issue, |
||||
PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE, |
||||
| 1092 | 24923208 |
US |
45 | 2 |
Product dose omission issue, Device issue, Pruritus, Rash, Product quality issue, |
||||
OMALIZUMAB, OMALIZUMAB, MONTELUKAST SODIUM, FAMOTIDINE, |
||||
| 1093 | 24923626 |
KR |
||
Device issue, |
||||
GOLIMUMAB, GOLIMUMAB, |
||||
| 1094 | 24923788 |
JP |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 1095 | 24923811 |
JP |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 1096 | 24923831 |
US |
53 | 1 |
Accidental exposure to product, Device issue, Drug dose omission by device, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, |
||||
| 1097 | 24923852 |
JP |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 1098 | 24923960 |
TR |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 1099 | 24923988 |
CL |
12 | 2 |
Device issue, Device material issue, |
||||
SOMATROPIN, |
||||
| 1100 | 24924005 |
CL |
||
Device 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.
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last_updated
2025-04-28