Drug:
Reaction: DEVICE ISSUE
20250101 - 20251231
No. 1 - 100
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 1 | 25491995 |
TR |
||
Device issue, Product dose omission issue, Product administered at inappropriate site, |
||||
GOLIMUMAB, |
||||
| 2 | 25492426 |
KR |
||
Device issue, |
||||
GOLIMUMAB, GOLIMUMAB, |
||||
| 3 | 25492524 |
US |
2 | |
Product storage error, Device issue, |
||||
RISANKIZUMAB-RZAA, |
||||
| 4 | 25492552 |
US |
||
Dyspnoea, Drug dose omission by device, Wrong technique in product usage process, Incorrect dose administered by device, Device issue, Device deposit issue, Device delivery system issue, |
||||
ALBUTEROL SULFATE, |
||||
| 5 | 25492644 |
US |
2 | |
Caesarean section, Device breakage, Foreign body in reproductive tract, Complication of device removal, Embedded device, Device issue, Device material issue, Procedural pain, Alopecia, Affective disorder, Uterine prolapse, Genital hypoaesthesia, Nervous system disorder, Cystocele, Uterine scar, Emotional disorder, Muscle spasms, Polymenorrhoea, Dyspareunia, Pain, Intermenstrual bleeding, |
||||
COPPER, |
||||
| 6 | 25493109 |
US |
2 | |
Adverse reaction, Device issue, |
||||
CERTOLIZUMAB PEGOL, |
||||
| 7 | 25493120 |
DE |
||
Device issue, Product dose omission issue, Device defective, |
||||
GUSELKUMAB, |
||||
| 8 | 25493269 |
US |
34 | 2 |
Abortion spontaneous, Device breakage, Foreign body in reproductive tract, Complication of device removal, Embedded device, Device issue, Device material issue, Depression, Premenstrual dysphoric disorder, Pain, |
||||
COPPER, ALBUTEROL SULFATE, DULOXETINE HYDROCHLORIDE, |
||||
| 9 | 25493518 |
US |
2 | |
Oxygen saturation abnormal, Asthma, Respiratory tract infection, Product dose omission issue, Device issue, |
||||
FLUTICASONE PROPIONATE AND SALMETEROL, FLUTICASONE PROPIONATE AND SALMETEROL, FLUTICASONE PROPIONATE AND SALMETEROL, FLUTICASONE PROPIONATE AND SALMETEROL, |
||||
| 10 | 25493615 |
US |
69 | 1 |
Needle issue, Device issue, COVID-19, |
||||
ABATACEPT, |
||||
| 11 | 25494791 |
US |
60 | 2 |
Accidental exposure to product, Product dose omission issue, Device issue, |
||||
GUSELKUMAB, |
||||
| 12 | 25495075 |
US |
73 | 2 |
Needle issue, Product dose omission issue, Device issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 13 | 25495232 |
US |
2 | |
Device issue, Accidental exposure to product, |
||||
GUSELKUMAB, |
||||
| 14 | 25495559 |
US |
67 | 1 |
Hospitalisation, Incorrect dose administered, Device issue, |
||||
INSULIN GLARGINE, |
||||
| 15 | 25495662 |
US |
2 | |
Blood glucose increased, Device issue, Expired product administered, |
||||
INSULIN GLARGINE, |
||||
| 16 | 25496482 |
US |
2 | |
Injection site reaction, Device issue, Injection site erythema, |
||||
ADALIMUMAB, |
||||
| 17 | 25496490 |
US |
46 | 2 |
Drug dose omission by device, Product administration error, Device issue, |
||||
ADALIMUMAB, ADALIMUMAB-FKJP, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE, DEXAMETHASONE, DEXAMETHASONE 1.5 MG, METHOCARBAMOL, METHOCARBAMOL TABLETS, OXYCODONE, |
||||
| 18 | 25491533 |
AT |
24 | 1 |
Paralysis, Device information output issue, Device breakage, Device issue, |
||||
FOSCARBIDOPA/FOSLEVODOPA, |
||||
| 19 | 25491535 |
FR |
79 | 1 |
Hallucination, visual, Infusion site nodule, Device issue, |
||||
FOSCARBIDOPA/FOSLEVODOPA, FOSCARBIDOPA/FOSLEVODOPA, |
||||
| 20 | 25491584 |
CA |
46 | 1 |
Deep brain stimulation, Device issue, Skin infection, Nodule, |
||||
FOSCARBIDOPA/FOSLEVODOPA, |
||||
| 21 | 25486580 |
US |
1 | |
Paranoia, Device issue, |
||||
ADALIMUMAB, |
||||
| 22 | 25486761 |
US |
2 | |
Injection site haemorrhage, Device issue, |
||||
ADALIMUMAB, |
||||
| 23 | 25486815 |
US |
||
Drug dose omission by device, Device delivery system issue, Device issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 24 | 25487097 |
US |
11 | 1 |
Product complaint, Product dose omission issue, Device issue, No adverse event, |
||||
OMALIZUMAB, OMALIZUMAB, |
||||
| 25 | 25487113 |
US |
2 | |
Diarrhoea, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 26 | 25487219 |
US |
81 | |
Off label use, Drug dose omission by device, Device deposit issue, Device malfunction, Expired product administered, Device issue, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 27 | 25487664 |
US |
2 | |
Auditory disorder, Device issue, |
||||
RISANKIZUMAB-RZAA, |
||||
| 28 | 25487695 |
US |
1 | |
Progressive supranuclear palsy, Device issue, |
||||
CARBIDOPA AND LEVODOPA, CARBIDOPA AND LEVODOPA, |
||||
| 29 | 25488230 |
CA |
||
Device issue, |
||||
CONJUGATED ESTROGENS, ESTROGENS, CONJUGATED, |
||||
| 30 | 25488562 |
US |
15 | |
Drug dose omission by device, Wrong technique in product usage process, Device use issue, Device issue, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 31 | 25488772 |
US |
1 | |
Device issue, Conjunctival erosion, Cataract, |
||||
RANIBIZUMAB, RANIBIZUMAB, RANIBIZUMAB, RANIBIZUMAB, RANIBIZUMAB, |
||||
| 32 | 25488913 |
US |
76 | 2 |
Incontinence, Weight increased, Fall, Fatigue, Memory impairment, Fibromyalgia, Brain fog, Spinal disorder, Confusional state, Device issue, |
||||
UPADACITINIB, UPADACITINIB, |
||||
| 33 | 25489017 |
US |
53 | 2 |
Eye irritation, Bacterial rhinitis, Eye discharge, Ocular discomfort, Product dose omission issue, Accidental exposure to product, Device defective, Device issue, |
||||
OMALIZUMAB, ETANERCEPT, ETANERCEPT, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, TIRZEPATIDE, ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITSLOPRAM, HYDROXYZINE, |
||||
| 34 | 25489203 |
US |
||
Injection site pain, Device issue, |
||||
INSULIN GLARGINE, |
||||
| 35 | 25489766 |
US |
2 | |
Device issue, Incorrect dose administered, |
||||
ONABOTULINUMTOXINA, |
||||
| 36 | 25481584 |
US |
||
Product dose omission issue, Device issue, No adverse event, Device malfunction, |
||||
OMALIZUMAB, |
||||
| 37 | 25481666 |
US |
||
Product use complaint, Device issue, Product quality issue, |
||||
MEDROXYPROGESTERONE ACETATE, |
||||
| 38 | 25481668 |
US |
||
Incorrect dose administered, Product use complaint, Device issue, |
||||
MEDROXYPROGESTERONE ACETATE, |
||||
| 39 | 25481877 |
US |
||
Device issue, Device delivery system issue, |
||||
MEDROXYPROGESTERONE ACETATE, |
||||
| 40 | 25482402 |
AT |
81 | 2 |
Device occlusion, Device occlusion, Incorrect route of product administration, Hypokinesia, Stoma site discharge, Stoma site erythema, Device issue, |
||||
| 41 | 25482469 |
US |
13 | 2 |
Device issue, Product complaint, Product dose omission issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 42 | 25482485 |
US |
2 | |
Infusion site pain, Dyspnoea, Feeling abnormal, Device issue, Device malfunction, Device occlusion, Device occlusion, Device power source issue, Device power source issue, Device power source issue, Device wireless communication issue, Device use error, |
||||
TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, NIFEDIPINE, DEXTROSE MONOHYDRATE, DEXTROSE, METHOCARBAMOL, METHOCARBAMOL TABLETS, METOCLOPRAMIDE HYDROCHLORIDE, DOCUSATE SODIUM AND SENNOSIDES, SENNOSIDES AND DOCUSATE SODIUM, SENNA-S, SENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MG, DOCUSATE SODIUM 50MG AND SENNOSIDES 8.6MG, SENNA AND DOCUSATE SODIUM TABLETS, 8.6 MG AND 50 MG, SENNOSIDES, DOCUSATE SODIUM, SENNOSIDES, SENNOSIDES 8.6 MG AND DOCUSATE SODIUM 50 MG, OXYCODONE HYDROCHLORIDE, OXYCODONE, SODIUM CHLORIDE, SODIUM CHLORIDE INJECTION, SODIUM CHLORIDE TABLET, SERTRALINE HYDROCHLORIDE, KETAMINE HYDROCHLORIDE, ALBUTEROL SULFATE, HYDROXYCHLOROQUINE SULFATE, LANSOPRAZOLE, PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE, FLUTICASONE PROPIONATE, PREDNISONE, CLONIDINE, KETOPROFEN, ALPRAZOLAM, AMIODARONE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE ANHYDROUS, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATED, ONDANSETRON HYDROCHLORIDE, POLYETHYLENE GLYCOL, ERGOCALCIFEROL, AMITRIPTYLINE HYDROCHLORIDE, GABAPENTIN, NITROGLYCERIN, |
||||
| 43 | 25482499 |
US |
||
Device issue, |
||||
NITRIC OXIDE, |
||||
| 44 | 25482500 |
US |
1 | |
Device issue, Underdose, |
||||
NITRIC OXIDE, |
||||
| 45 | 25482501 |
US |
||
Device issue, |
||||
NITRIC OXIDE, |
||||
| 46 | 25482642 |
US |
1 | |
Drug dose omission by device, Device issue, |
||||
ADALIMUMAB-ADAZ, |
||||
| 47 | 25482735 |
US |
2 | |
Pain, Device issue, |
||||
OMALIZUMAB, |
||||
| 48 | 25483137 |
US |
87 | 2 |
Product taste abnormal, Device delivery system issue, Device issue, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE, BUDESONIDE AND FORMOTEROL FUMARATE, BUDESONIDE AND FORMOTEROL FUMARATE, BUDESONIDE AND FORMOTEROL FUMARATE, BUDESONIDE AND FORMOTEROL FUMARATE, BUDESONIDE AND FORMOTEROL FUMARATE, BUDESONIDE AND FORMOTEROL FUMARATE, BUDESONIDE AND FORMOTEROL FUMARATE, AMLODIPINE, AMLODIPINE, AMLODIPINE, AMLODIPINE, METOPROLOL TARTRATE, METOPROLOL, METOPROLOL TARTRATE, METOPROLOL, METOPROLOL TARTRATE, METOPROLOL, METOPROLOL TARTRATE, METOPROLOL, RABEPRAZOLE, RABEPRAZOLE, RABEPRAZOLE, RABEPRAZOLE, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 49 | 25484156 |
US |
78 | 2 |
Injection site pain, Device issue, |
||||
INSULIN GLARGINE, |
||||
| 50 | 25484330 |
US |
2 | |
Injection site pain, Device issue, |
||||
SARILUMAB, |
||||
| 51 | 25484777 |
US |
1 | |
Product dose omission issue, Device issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 52 | 25485174 |
US |
37 | 1 |
Device issue, Injection site reaction, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 53 | 25485486 |
CO |
11 | 1 |
Device issue, |
||||
SOMATROPIN, |
||||
| 54 | 25486191 |
US |
78 | 1 |
Injection site discomfort, Injection site urticaria, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 55 | 25486213 |
AR |
76 | 2 |
Visual impairment, Device issue, |
||||
GOLIMUMAB, |
||||
| 56 | 25476026 |
US |
2 | |
Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 57 | 25476095 |
US |
2 | |
Device issue, Injection site haemorrhage, Accidental exposure to product, Incorrect dose administered by device, Device leakage, |
||||
OFATUMUMAB, |
||||
| 58 | 25476149 |
US |
2 | |
Drug dose omission by device, Device issue, |
||||
ALBUTEROL SULFATE, |
||||
| 59 | 25476371 |
AU |
90 | 1 |
Hyperglycaemia, Device failure, Device issue, Device leakage, Product quality issue, Fatigue, Discomfort, Flushing, Head discomfort, Drug dose omission by device, |
||||
| 60 | 25476469 |
US |
1 | |
Intercepted product preparation error, Device issue, |
||||
LEUPROLIDE ACETATE, LEUPROLIDE ACETATE, LEUPROLIDE ACETATE, |
||||
| 61 | 25476774 |
BR |
||
Device issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 62 | 25477030 |
US |
62 | 2 |
Swelling, Pain, Systemic lupus erythematosus, Nerve injury, Product dose omission issue, Device issue, |
||||
TOCILIZUMAB, |
||||
| 63 | 25477506 |
US |
||
Device issue, |
||||
NITRIC OXIDE, |
||||
| 64 | 25477511 |
US |
29 | 2 |
Abortion spontaneous, Ectopic pregnancy, Surgery, Oophorectomy, Salpingectomy, Reproductive complication associated with device, Pregnancy with contraceptive device, Drug ineffective, Embedded device, Device breakage, Foreign body in urogenital tract, Complication of device removal, Device issue, Emotional distress, Emotional disorder, Device dislocation, Pelvic pain, |
||||
COPPER, WARFARIN, |
||||
| 65 | 25477881 |
US |
2 | |
Injection site pain, Device difficult to use, Device issue, Device delivery system issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 66 | 25477941 |
US |
58 | 2 |
Postmenopausal haemorrhage, Product administration error, Product adhesion issue, Device issue, |
||||
| 67 | 25478510 |
US |
||
Product storage error, Device issue, No adverse event, |
||||
LEVALBUTEROL TARTRATE, |
||||
| 68 | 25478526 |
US |
2 | |
Crohn^s disease, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 69 | 25478666 |
US |
45 | 2 |
Herpes zoster, Oral herpes, Pulmonary hypertension, Off label use, Device occlusion, Device occlusion, Device issue, Device issue, Device infusion issue, Device infusion issue, Unevaluable device issue, |
||||
TREPROSTINIL, TREPROSTINIL, SELEXIPAG, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, FLUTICASONE FUROATE AND VILANTEROL TRIFENATATE, SODIUM CHLORIDE, SODIUM CHLORIDE INJECTION, SODIUM CHLORIDE TABLET, CYANOCOBALAMIN, ERGOCALCIFEROL, ALBUTEROL SULFATE, ALLOPURINOL, MACITENTAN, EPINEPHRINE, OXYGEN, 0XYGEN, COLCHICINE, RIOCIGUAT, VILAZODONE HYDROCHLORIDE, ADALIMUMAB, ONDANSETRON HYDROCHLORIDE, OXYCODONE AND ACETAMINOPHEN, OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN, OXYCODONE AND ACETAMINOPHEN TABLETS, |
||||
| 70 | 25478845 |
US |
||
Product storage error, Device issue, |
||||
| 71 | 25479050 |
AU |
74 | 1 |
Urinary retention, Device issue, Sepsis, |
||||
| 72 | 25480122 |
US |
2 | |
Injection site pain, Wrong technique in device usage process, Device issue, |
||||
GLATIRAMER ACETATE, GLATIRAMER, |
||||
| 73 | 25480526 |
US |
12 | 1 |
Drug dose omission by device, Device leakage, Device issue, |
||||
SOMATROPIN, |
||||
| 74 | 25480866 |
US |
42 | |
Device issue, Product dose omission issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 75 | 25481042 |
US |
2 | |
Circumstance or information capable of leading to medication error, Device issue, |
||||
ADALIMUMAB-ADAZ, ADALIMUMAB-ADAZ, |
||||
| 76 | 25470701 |
US |
1 | |
Accidental exposure to product, Device issue, No adverse event, |
||||
TOCILIZUMAB, |
||||
| 77 | 25470987 |
TR |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 78 | 25471050 |
US |
1 | |
Device delivery system issue, Device issue, Wrong technique in product usage process, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 79 | 25471267 |
NL |
||
Device issue, Product dose omission issue, Off label use, |
||||
GOLIMUMAB, |
||||
| 80 | 25471275 |
US |
||
Therapy cessation, Device use issue, Device issue, |
||||
ALBUTEROL SULFATE AND BUDESONIDE, |
||||
| 81 | 25471766 |
US |
1 | |
Product preparation error, Device issue, |
||||
LEUPROLIDE ACETATE, |
||||
| 82 | 25472159 |
US |
1 | |
Stress, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 83 | 25472215 |
US |
63 | 2 |
Device issue, Liquid product physical issue, Liquid product physical issue, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
| 84 | 25472814 |
US |
||
Asthma, Device delivery system issue, Wrong technique in product usage process, Product cleaning inadequate, Device issue, Product dose omission issue, Device breakage, |
||||
ALBUTEROL SULFATE AND BUDESONIDE, |
||||
| 85 | 25472995 |
US |
1 | |
Injection site reaction, Device issue, |
||||
ADALIMUMAB, |
||||
| 86 | 25473221 |
US |
||
Wrong technique in product usage process, Device issue, No adverse event, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 87 | 25474275 |
AU |
||
Device issue, |
||||
DARUNAVIR, DARUNAVIR, |
||||
| 88 | 25474368 |
JP |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 89 | 25475288 |
US |
62 | 2 |
Device issue, Injection site papule, |
||||
ADALIMUMAB, |
||||
| 90 | 25475664 |
US |
73 | 1 |
Intervertebral disc degeneration, Intervertebral disc degeneration, Venous repair, Thrombosis, Device issue, |
||||
RISANKIZUMAB-RZAA, LISINOPRIL, |
||||
| 91 | 25475667 |
AR |
29 | 2 |
Product dose omission issue, Device issue, |
||||
GOLIMUMAB, |
||||
| 92 | 25475719 |
US |
72 | 2 |
Cardiac failure congestive, Asthma, Device issue, |
||||
RISANKIZUMAB-RZAA, |
||||
| 93 | 25475732 |
US |
1 | |
Skin haemorrhage, Device issue, |
||||
ADALIMUMAB, |
||||
| 94 | 25475742 |
US |
2 | |
Circumstance or information capable of leading to medication error, Device issue, |
||||
ADALIMUMAB-ADAZ, |
||||
| 95 | 25465551 |
US |
2 | |
Injection site reaction, Device issue, |
||||
ADALIMUMAB, |
||||
| 96 | 25465570 |
US |
76 | 2 |
Liquid product physical issue, Injection site papule, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, TRIAMTERENE CAPSULES, TRIAMTERENE, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, LEVOTHYROXINE, |
||||
| 97 | 25465752 |
US |
2 | |
Hospitalisation, Device issue, |
||||
ADALIMUMAB, |
||||
| 98 | 25465936 |
US |
83 | 1 |
Blood glucose increased, Incorrect dose administered, Device issue, |
||||
INSULIN GLARGINE, |
||||
| 99 | 25466200 |
US |
44 | |
Mental disorder, Device issue, |
||||
ADALIMUMAB, |
||||
| 100 | 25466383 |
US |
2 | |
Product dose omission issue, Device issue, Product container issue, |
||||
FLUTICASONE PROPIONATE, |
||||
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
2025-07-29