Drug:
Reaction: DEVICE ISSUE
20250101 - 20251231
No. 401 - 500
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 401 | 25064689 |
CA |
37 | 2 |
Product dose omission issue, Device issue, Off label use, Faecal calprotectin increased, Fear, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 402 | 25065120 |
US |
1 | |
Device issue, Needle issue, Haemorrhage, Product dose omission issue, Accidental exposure to product, |
||||
GUSELKUMAB, |
||||
| 403 | 25065138 |
US |
79 | 2 |
Injection site haemorrhage, Injection site reaction, Device issue, |
||||
ADALIMUMAB, METOPROLOL TARTRATE, METOPROLOL, APIXABAN, |
||||
| 404 | 25065178 |
US |
53 | 1 |
Circumstance or information capable of leading to medication error, Device issue, |
||||
ADALIMUMAB-ADAZ, |
||||
| 405 | 25065289 |
US |
42 | 1 |
Exposure via skin contact, Incorrect dose administered by device, Accidental exposure to product, Device issue, |
||||
ADALIMUMAB-ADAZ, ADALIMUMAB-ADAZ, |
||||
| 406 | 25065330 |
DE |
2 | |
Device issue, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
| 407 | 25065394 |
BR |
||
Product dose omission issue, Accidental exposure to product, Device issue, |
||||
GUSELKUMAB, |
||||
| 408 | 25065700 |
US |
||
Device issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 409 | 25065833 |
US |
2 | |
Autism spectrum disorder, Device issue, |
||||
ADALIMUMAB, |
||||
| 410 | 25056412 |
US |
||
Device issue, Product dose omission issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 411 | 25056508 |
US |
51 | 2 |
Device issue, Therapeutic product effect decreased, |
||||
ADALIMUMAB, ADALIMUMAB, |
||||
| 412 | 25056525 |
US |
77 | 1 |
Device issue, Product label issue, Device leakage, Product quality issue, Device malfunction, Product dose omission issue, Device issue, |
||||
GUSELKUMAB, GUSELKUMAB, |
||||
| 413 | 25056550 |
US |
1 | |
Dyspnoea, Oxygen saturation decreased, Drug ineffective, Device issue, |
||||
TIOTROPIUM BROMIDE, |
||||
| 414 | 25057042 |
CA |
63 | 1 |
Device malfunction, Device issue, Injection site swelling, Injection site pruritus, Device delivery system issue, Incorrect dose administered by device, Product storage error, |
||||
SEMAGLUTIDE, |
||||
| 415 | 25057154 |
AR |
71 | 2 |
Spinal fracture, Device issue, Osteoporosis, Fall, |
||||
GOLIMUMAB, |
||||
| 416 | 25057561 |
US |
||
Treatment delayed, Product contamination physical, Device occlusion, Device issue, |
||||
NALOXONE HYDROCHLORIDE, NALOXONE, NALXONE HYDROCHLORIDE, |
||||
| 417 | 25057606 |
US |
47 | 2 |
Arthralgia, Pain in extremity, Device issue, |
||||
ADALIMUMAB, BUPROPION HYDROCHLORIDE, BUPROPION, METHOTREXATE, METHOTREXATE SODIUM, SEMAGLUTIDE, SERTRALINE, |
||||
| 418 | 25057615 |
US |
29 | 1 |
Hospitalisation, Device issue, Product quality issue, Incorrect dose administered by device, Product dose omission issue, |
||||
PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE, |
||||
| 419 | 25057647 |
US |
2 | |
Hypersomnia, Product administration error, Device issue, Device breakage, Product adhesion issue, Therapeutic product ineffective, |
||||
| 420 | 25057675 |
US |
50 | 1 |
Hospitalisation, Device issue, |
||||
ADALIMUMAB, |
||||
| 421 | 25058739 |
US |
2 | |
Multiple sclerosis, Speech disorder, Muscular weakness, Memory impairment, Gait disturbance, Back pain, Fall, Device issue, |
||||
OFATUMUMAB, |
||||
| 422 | 25058763 |
DE |
79 | 1 |
Haematochezia, Pneumonia, Decubitus ulcer, Product administration error, Hospitalisation, Incorrect route of product administration, Dysphagia, Device issue, Asthenia, Gait inability, |
||||
QUETIAPINE, QUETIAPINE EXTENDED-RELEASE, RIVASTIGMINE, CITALOPRAM, CITALOPRAM HYDROBROMIDE, ENTACAPONE, PRAMIPEXOLE, SAFINAMIDE MESYLATE, |
||||
| 423 | 25058778 |
US |
54 | 2 |
Incorrect dose administered, Product dose omission issue, Product complaint, Device issue, No adverse event, |
||||
OMALIZUMAB, OMALIZUMAB, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, DIPHENHYDRAMINE HYDROCHLORIDE, |
||||
| 424 | 25058939 |
US |
31 | 2 |
Intestinal obstruction, Drug ineffective, Crohn^s disease, Device issue, Escherichia infection, Nausea, Decreased appetite, Insomnia, Haematochezia, Gastrointestinal sounds abnormal, Constipation, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 425 | 25059033 |
US |
23 | 1 |
Injection site swelling, Injection site haemorrhage, Device issue, |
||||
ADALIMUMAB, |
||||
| 426 | 25059449 |
US |
2 | |
Hospitalisation, Device issue, Malaise, |
||||
ADALIMUMAB, |
||||
| 427 | 25059481 |
US |
23 | 2 |
Complication of device removal, Device issue, Device deployment issue, No adverse event, |
||||
ETONOGESTREL, |
||||
| 428 | 25059498 |
US |
65 | 1 |
Intercepted product preparation error, Device issue, |
||||
LEUPROLIDE ACETATE, |
||||
| 429 | 25059499 |
US |
72 | 1 |
Intercepted product preparation error, Device issue, |
||||
LEUPROLIDE ACETATE, LEUPROLIDE ACETATE, |
||||
| 430 | 25059500 |
US |
1 | |
Intercepted product preparation error, Device issue, |
||||
LEUPROLIDE ACETATE, LEUPROLIDE ACETATE, LEUPROLIDE ACETATE, |
||||
| 431 | 25059641 |
GB |
1 | |
Infection, Fall, Confusional state, Device issue, Device connection issue, |
||||
| 432 | 25059892 |
US |
2 | |
Inappropriate schedule of product administration, Circumstance or information capable of leading to medication error, Device issue, Device delivery system issue, |
||||
FLUTICASONE PROPIONATE AND SALMETEROL, |
||||
| 433 | 25060556 |
US |
26 | 2 |
Wrong technique in device usage process, Exposure via skin contact, Product dose omission issue, Device issue, Device difficult to use, No adverse event, |
||||
OMALIZUMAB, OMALIZUMAB, PREDNISONE, |
||||
| 434 | 25060904 |
US |
2 | |
Pain in extremity, Device issue, Fatigue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 435 | 25061065 |
EG |
10 | 1 |
Therapy cessation, Incorrect dose administered by device, Drug dose omission by device, Wrong technique in product usage process, Product odour abnormal, Poor quality device used, Product availability issue, Device issue, Product substitution, |
||||
SOMATROPIN, SOMATROPIN, SOMATROPIN, |
||||
| 436 | 25061176 |
TR |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 437 | 25061179 |
US |
62 | 2 |
Shoulder fracture, Device issue, Shoulder fracture, Fall, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 438 | 25061194 |
US |
42 | 2 |
Injection site haemorrhage, Device issue, |
||||
ADALIMUMAB, |
||||
| 439 | 25061227 |
US |
65 | 2 |
Device issue, Product dose omission issue, Off label use, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 440 | 25055753 |
US |
2 | |
Device issue, Product odour abnormal, |
||||
TROFINETIDE, |
||||
| 441 | 25056111 |
US |
2 | |
Device issue, Incorrect dose administered by device, |
||||
ESKETAMINE HYDROCHLORIDE, |
||||
| 442 | 25054663 |
US |
34 | 2 |
Sepsis, Device issue, |
||||
ADALIMUMAB, ADALIMUMAB, |
||||
| 443 | 25054693 |
US |
62 | 2 |
Shoulder fracture, Fall, Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 444 | 25054698 |
CH |
72 | 1 |
Tremor, Pneumonia, Device issue, Device dislocation, Stress, Tremor, |
||||
| 445 | 25054798 |
US |
74 | 2 |
Injection site haemorrhage, Device issue, |
||||
ADALIMUMAB, |
||||
| 446 | 25054882 |
US |
2 | |
Infusion site haemorrhage, Device maintenance issue, Device issue, |
||||
TREPROSTINIL, TREPROSTINIL, ACETAMINOPHEN, POTASSIUM CHLORIDE, POTASSIUM CHLORIDE EXTENDED-RELEASE, POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE, POTASSIUM CHLORIDE ORAL, ETONOGESTREL, OXYGEN, 0XYGEN, BUMETANIDE, SPIRONOLACTONE, PROCHLORPERAZINE MALEATE, CETIRIZINE HCL, CETIRIZINE, TADALAFIL, AMBRISENTAN, |
||||
| 447 | 25055099 |
US |
87 | 2 |
Fractured coccyx, Fall, Asthenia, Dyspnoea, Lethargy, Painful respiration, Device issue, Off label use, |
||||
TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, AMLODIPINE BESYLATE, FUROSEMIDE, FOLIC ACID, ERGOCALCIFEROL, TADALAFIL, METHOTREXATE, METHOTREXATE SODIUM, OXYGEN, 0XYGEN, CALCIUM CARBONATE, ANTACID, ESCITALOPRAM OXALATE, ESCITALOPRAM, |
||||
| 448 | 25055296 |
US |
72 | 2 |
Colon cancer, Gastritis, Constipation, Inflammation, Adverse drug reaction, Urticaria, Device issue, Diarrhoea, Injection site discharge, |
||||
RISANKIZUMAB-RZAA, DULOXETINE HYDROCHLORIDE, |
||||
| 449 | 25055358 |
US |
73 | 2 |
Injury associated with device, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 450 | 25048338 |
US |
53 | 2 |
Device issue, Product dose omission issue, |
||||
GOLIMUMAB, |
||||
| 451 | 25048371 |
US |
1 | |
Accidental exposure to product, Device malfunction, Device issue, Drug dose omission by device, |
||||
SECUKINUMAB, AMLODIPINE, TIRZEPATIDE, |
||||
| 452 | 25048404 |
US |
2 | |
Drug dose omission by device, Device issue, |
||||
ADALIMUMAB, ADALIMUMAB-FKJP, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, |
||||
| 453 | 25048759 |
US |
78 | 1 |
Injection site bruising, Device issue, Product administered at inappropriate site, Off label use, |
||||
ADALIMUMAB-BWWD, |
||||
| 454 | 25048845 |
US |
55 | 2 |
Injection site pain, Device issue, |
||||
ADALIMUMAB-BWWD, |
||||
| 455 | 25048889 |
US |
72 | 2 |
Injection site pain, Device issue, |
||||
ADALIMUMAB-BWWD, |
||||
| 456 | 25049346 |
US |
||
Device issue, |
||||
NITRIC OXIDE, |
||||
| 457 | 25049479 |
US |
25 | 2 |
Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Emotional distress, Depression, Post-traumatic stress disorder, Nausea, Complication associated with device, Device issue, Heavy menstrual bleeding, Abdominal pain, |
||||
COPPER, |
||||
| 458 | 25049482 |
US |
26 | 2 |
Hysterectomy, Reproductive complication associated with device, Suicidal ideation, Device breakage, Foreign body in reproductive tract, Complication of device removal, Uterine perforation, Embedded device, Device issue, Complication associated with device, Mental disorder, Depression, Anxiety, Fear, Pelvic pain, Device dislocation, Pain, |
||||
COPPER, DIVALPROEX SODIUM, |
||||
| 459 | 25049483 |
ES |
10 | 2 |
Drug dose omission by device, Device issue, |
||||
SOMATROPIN, |
||||
| 460 | 25049603 |
US |
78 | 2 |
Injection site pain, Exposure via skin contact, Accidental exposure to product, Device issue, Incorrect dose administered, |
||||
ADALIMUMAB-BWWD, |
||||
| 461 | 25049651 |
US |
53 | 1 |
Injection site pain, Device issue, Incorrect dose administered, Product use issue, |
||||
ADALIMUMAB-BWWD, |
||||
| 462 | 25049653 |
US |
62 | 2 |
Injection site scar, Device issue, |
||||
ADALIMUMAB-BWWD, |
||||
| 463 | 25049655 |
US |
1 | |
Injection site bruising, Product administration error, Device issue, Incorrect dose administered, |
||||
ADALIMUMAB-BWWD, |
||||
| 464 | 25049659 |
US |
||
Injection site pain, Injection site bruising, Product substitution issue, Device issue, |
||||
ADALIMUMAB-BWWD, |
||||
| 465 | 25049664 |
US |
1 | |
Injection site erythema, Device issue, Wrong technique in product usage process, |
||||
ADALIMUMAB-BWWD, |
||||
| 466 | 25049665 |
US |
66 | 2 |
Injection site pain, Injection site haemorrhage, Exposure via skin contact, Accidental exposure to product, Device issue, |
||||
ADALIMUMAB-BWWD, ADALIMUMAB-BWWD, |
||||
| 467 | 25049677 |
US |
2 | |
Hospitalisation, Skin cancer, Urticaria, Illness, Feeling abnormal, Device issue, Off label use, Wrong technique in product usage process, Drug dose omission by device, Device use issue, |
||||
AMIKACIN, AMIKACIN, AMIKACIN, AMIKACIN, AZITHROMYCIN, AZITHROMYCIN MONOHYDRATE, AZITHROMYCIN DIHYDRATE, |
||||
| 468 | 25050006 |
US |
||
Drug ineffective, Product packaging quantity issue, Device issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 469 | 25050202 |
US |
26 | 1 |
Pulmonary function test decreased, Cough, Insurance issue, Product dose omission issue, Therapy interrupted, Product distribution issue, Device issue, Drug dose omission by device, |
||||
AMIKACIN, AMIKACIN, AZITHROMYCIN, AZITHROMYCIN MONOHYDRATE, AZITHROMYCIN DIHYDRATE, OMADACYCLINE, |
||||
| 470 | 25050273 |
US |
87 | 1 |
Injection site haemorrhage, Wrong technique in product usage process, Device audio issue, Incorrect dose administered, Device issue, |
||||
ADALIMUMAB-BWWD, |
||||
| 471 | 25051008 |
EG |
11 | 2 |
Gait disturbance, Pain in extremity, Growth retardation, Expired device used, Drug dose omission by device, Device issue, Drug administered in wrong device, Therapy cessation, |
||||
SOMATROPIN, |
||||
| 472 | 25051106 |
US |
28 | 2 |
Injection site erythema, Injury associated with device, Device leakage, Device issue, |
||||
ADALIMUMAB-BWWD, |
||||
| 473 | 25051147 |
US |
70 | 1 |
Injection site discolouration, Device issue, Product substitution issue, Off label use, |
||||
ADALIMUMAB-BWWD, |
||||
| 474 | 25051155 |
US |
75 | 2 |
Injection site pain, Injection site erythema, Injection site haemorrhage, Injection site bruising, Device issue, Device leakage, Wrong technique in device usage process, |
||||
ADALIMUMAB-BWWD, |
||||
| 475 | 25051156 |
US |
60 | 1 |
Agitation, Patient uncooperative, Accidental exposure to product, Exposure via skin contact, Device issue, |
||||
ADALIMUMAB-BWWD, |
||||
| 476 | 25051228 |
CA |
69 | 1 |
Purulence, Catheter site erythema, Device temperature issue, Infusion site reaction, Nodule, Delirium, Catheter site pain, Mobility decreased, Rash, Papule, Pain, Gait disturbance, Device issue, Injection site erythema, Frustration tolerance decreased, Pneumonia, Electric shock, Injection site discharge, Device electrical finding, Localised infection, Device loosening, Infusion site abscess, Somnolence, Intentional medical device removal by patient, Adverse drug reaction, Inflammation, Hypersomnia, Dermatitis, |
||||
FOSCARBIDOPA/FOSLEVODOPA, FOSCARBIDOPA/FOSLEVODOPA, |
||||
| 477 | 25051633 |
US |
44 | 2 |
Off label use, Device issue, Product dose omission issue, Asthma, Respiratory disorder, Peak expiratory flow rate decreased, Urticaria, Headache, Nausea, Epistaxis, Sinusitis, |
||||
OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, TEZEPELUMAB-EKKO, |
||||
| 478 | 25051777 |
US |
1 | |
Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, |
||||
| 479 | 25052011 |
US |
55 | 1 |
Injection site papule, Device issue, Injection site mass, |
||||
RISANKIZUMAB-RZAA, |
||||
| 480 | 25052080 |
US |
57 | 1 |
Injection site haemorrhage, Device issue, Incorrect dose administered, Exposure via skin contact, Accidental exposure to product, |
||||
ADALIMUMAB-BWWD, |
||||
| 481 | 25052081 |
US |
57 | 2 |
Injection site haemorrhage, Device leakage, Device issue, Exposure via skin contact, Accidental exposure to product, |
||||
ADALIMUMAB-BWWD, HYDROXYCHLOROQUINE, |
||||
| 482 | 25052116 |
US |
56 | 2 |
Swelling, Nausea, Malaise, Device issue, |
||||
ADALIMUMAB-BWWD, |
||||
| 483 | 25052272 |
US |
19 | 2 |
Injection site urticaria, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 484 | 25052767 |
US |
56 | 2 |
Blood glucose increased, Device issue, Product dispensing error, Product storage error, |
||||
INSULIN GLARGINE, |
||||
| 485 | 25052773 |
US |
71 | 2 |
Injection site bruising, Injection site swelling, Injection site pain, Rash, Exposure via skin contact, Device mechanical issue, Accidental exposure to product, Device issue, |
||||
DUPILUMAB, DUPILUMAB, DUPILUMAB, |
||||
| 486 | 25053195 |
US |
83 | 1 |
Blood glucose increased, Drug ineffective, Device issue, |
||||
INSULIN GLARGINE, INSULIN LISPRO, |
||||
| 487 | 25053586 |
US |
74 | 1 |
Blood glucose increased, Device issue, Inappropriate schedule of product administration, |
||||
INSULIN GLARGINE, |
||||
| 488 | 25054100 |
US |
87 | 2 |
Blood glucose increased, Drug dose omission by device, Device issue, |
||||
INSULIN GLARGINE, |
||||
| 489 | 25043470 |
US |
80 | 2 |
Underdose, Wrong technique in product usage process, Device issue, Needle issue, No adverse event, |
||||
TOCILIZUMAB, |
||||
| 490 | 25043756 |
DE |
2 | |
Device issue, |
||||
GOLIMUMAB, |
||||
| 491 | 25043883 |
US |
2 | |
Cardiac operation, Fall, Rib fracture, Cystitis, Contusion, Hospitalisation, Device issue, |
||||
RISANKIZUMAB-RZAA, |
||||
| 492 | 25044269 |
US |
1 | |
Injection site bruising, Wrong technique in device usage process, Device issue, Device breakage, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 493 | 25044534 |
CA |
32 | 2 |
Ankylosing spondylitis, Anxiety, Injection site pain, Bladder disorder, Illness, Prolonged labour, Device issue, Maternal exposure before pregnancy, Maternal exposure during pregnancy, |
||||
CERTOLIZUMAB PEGOL, CERTOLIZUMAB PEGOL, CERTOLIZUMAB PEGOL, |
||||
| 494 | 25044809 |
US |
2 | |
Maternal exposure during pregnancy, Live birth, Device issue, Injection site haemorrhage, |
||||
ADALIMUMAB, ADALIMUMAB, ADALIMUMAB, |
||||
| 495 | 25044908 |
US |
61 | 2 |
Device issue, |
||||
PEGFILGRASTIM, |
||||
| 496 | 25045058 |
US |
2 | |
Product delivery mechanism issue, Device issue, No adverse event, |
||||
IPRATROPIUM BROMIDE, |
||||
| 497 | 25045138 |
US |
13 | 1 |
COVID-19, Product storage error, Device issue, |
||||
SOMATROPIN, SOMATROPIN, SOMATROPIN, SOMATROPIN, SOMATROPIN, SOMATROPIN, |
||||
| 498 | 25045781 |
US |
73 | 2 |
Injection site pain, Device issue, Product substitution, |
||||
ADALIMUMAB-BWWD, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, FAMOTIDINE, PREDNISONE, SIMVASTATIN, HYDROCHLOROTHIAZIDE, |
||||
| 499 | 25045965 |
US |
26 | 2 |
Injection site pain, Needle issue, Wrong technique in product usage process, Device issue, |
||||
ADALIMUMAB-BWWD, |
||||
| 500 | 25046016 |
US |
65 | 2 |
Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
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