Drug:
Reaction: DEVICE MALFUNCTION
20260101 - 20261231
No. 301 - 400
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 301 | 26494732 |
CN |
1 | |
Device issue, Device malfunction, |
||||
| 302 | 26494943 |
US |
||
Device malfunction, No adverse event, Device malfunction, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 303 | 26495801 |
US |
||
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 304 | 26485948 |
GB |
31 | 2 |
Lower respiratory tract infection, Condition aggravated, Injection site haemorrhage, Haemoptysis, Influenza like illness, Fatigue, Pain, Headache, Paraesthesia oral, Fatigue, Cough, Device malfunction, Accidental exposure to product, |
||||
OFATUMUMAB, OFATUMUMAB, |
||||
| 305 | 26486432 |
US |
47 | 2 |
Device malfunction, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, |
||||
| 306 | 26486725 |
US |
||
Injection site haemorrhage, Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 307 | 26487107 |
US |
70 | 2 |
Anxiety, Device malfunction, |
||||
TEZEPELUMAB-EKKO, TEZEPELUMAB-EKKO, |
||||
| 308 | 26487287 |
US |
||
Device malfunction, No adverse event, Device malfunction, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 309 | 26487591 |
US |
29 | 2 |
Accidental exposure to product, Drug dose omission by device, Device leakage, Device malfunction, |
||||
SECUKINUMAB, |
||||
| 310 | 26487685 |
US |
||
Intentional product use issue, Product dose omission issue, Device malfunction, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 311 | 26488022 |
|||
Incorrect dose administered, Device malfunction, Product dose omission issue, |
||||
BIMEKIZUMAB, |
||||
| 312 | 26488449 |
28 | ||
Hidradenitis, Injection site swelling, Incorrect dose administered, Device malfunction, Device leakage, |
||||
BIMEKIZUMAB, |
||||
| 313 | 26489524 |
US |
1 | |
Device malfunction, Drug delivery system issue, |
||||
ESKETAMINE HYDROCHLORIDE, |
||||
| 314 | 26489736 |
US |
||
Drug dose omission by device, Device malfunction, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 315 | 26490102 |
US |
70 | 2 |
Wrong technique in product usage process, Circumstance or information capable of leading to medication error, Device mechanical issue, Device delivery system issue, Device malfunction, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE, BUDESONIDE AND FORMOTEROL FUMARATE, BUDESONIDE AND FORMOTEROL FUMARATE, BUDESONIDE AND FORMOTEROL FUMARATE, |
||||
| 316 | 26490330 |
US |
||
Device malfunction, |
||||
PEGFILGRASTIM, |
||||
| 317 | 26490399 |
US |
2 | |
Device delivery system issue, Incorrect dose administered, Device malfunction, |
||||
TEZEPELUMAB-EKKO, TEZEPELUMAB-EKKO, |
||||
| 318 | 26490517 |
US |
32 | 2 |
Injection site reaction, Injection site pain, Weight decreased, Device malfunction, Drug dose omission by device, |
||||
FREMANEZUMAB-VFRM, |
||||
| 319 | 26490891 |
US |
26 | 2 |
Colitis ulcerative, Device malfunction, Product dose omission issue, Injection site pain, Incorrect dose administered, Injection site swelling, |
||||
VEDOLIZUMAB, VEDOLIZUMAB, FEXOFENADINE HYDROCHLORIDE, ERGOCALCIFEROL, |
||||
| 320 | 26490952 |
US |
76 | 1 |
Device malfunction, Product use issue, Insomnia, Dyspnoea, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, |
||||
| 321 | 26490986 |
48 | ||
Injection site erythema, Product dose omission issue, Device malfunction, |
||||
BIMEKIZUMAB, |
||||
| 322 | 26491267 |
US |
2 | |
Device defective, Device deployment issue, Device delivery system issue, Accidental exposure to product, Exposure via skin contact, Drug dose omission by device, Device malfunction, |
||||
SECUKINUMAB, |
||||
| 323 | 26491304 |
US |
1 | |
Device deployment issue, Device delivery system issue, Device malfunction, Product leakage, |
||||
SECUKINUMAB, |
||||
| 324 | 26491437 |
55 | ||
Neoplasm malignant, Injection site bruising, Wrong technique in product usage process, Device malfunction, Product dose omission issue, Incorrect dose administered, |
||||
BIMEKIZUMAB, BIMEKIZUMAB, |
||||
| 325 | 26480330 |
US |
12 | |
Device malfunction, Wrong technique in product usage process, Exposure via skin contact, Product use issue, Drug dose omission by device, |
||||
ADALIMUMAB-AATY, ADALIMUMAB-AATY, |
||||
| 326 | 26480345 |
US |
||
Device malfunction, No adverse event, Device malfunction, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 327 | 26480349 |
US |
79 | |
Drug dose omission by device, Wrong technique in product usage process, Device malfunction, Device delivery system issue, No adverse event, |
||||
TIOTROPIUM BROMIDE, |
||||
| 328 | 26480361 |
US |
||
Device malfunction, Exposure via skin contact, Accidental exposure to product, |
||||
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, |
||||
| 329 | 26480389 |
US |
33 | |
Device malfunction, Drug dose omission by device, Intentional product use issue, |
||||
ADALIMUMAB-AATY, ADALIMUMAB-AATY, |
||||
| 330 | 26480581 |
US |
41 | |
Device malfunction, Drug dose omission by device, |
||||
INFLIXIMAB-DYYB, |
||||
| 331 | 26480632 |
US |
||
Device malfunction, Product use issue, Drug dose omission by device, |
||||
INFLIXIMAB-DYYB, |
||||
| 332 | 26480679 |
US |
18 | |
Device malfunction, Incorrect dose administered by device, |
||||
INFLIXIMAB-DYYB, |
||||
| 333 | 26480943 |
US |
||
Device malfunction, Product dose omission issue, Accidental exposure to product, |
||||
GUSELKUMAB, GUSELKUMAB, GUSELKUMAB, GUSELKUMAB, |
||||
| 334 | 26481484 |
US |
2 | |
Device mechanical issue, Incorrect dose administered by device, Device malfunction, |
||||
SECUKINUMAB, |
||||
| 335 | 26481532 |
US |
69 | 2 |
Incorrect dose administered by device, Device malfunction, Drug dose omission by device, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, |
||||
| 336 | 26481718 |
US |
1 | |
Device malfunction, No adverse event, Device malfunction, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 337 | 26481742 |
US |
||
Pruritus, Product dose omission issue, Device malfunction, Intentional overdose, Off label use, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 338 | 26481794 |
US |
77 | 2 |
Device malfunction, Accidental exposure to product, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, |
||||
| 339 | 26481811 |
US |
||
Device malfunction, |
||||
NITRIC OXIDE, |
||||
| 340 | 26481812 |
US |
||
Device malfunction, |
||||
NITRIC OXIDE, |
||||
| 341 | 26481921 |
US |
23 | |
Device malfunction, Accidental exposure to product, Exposure via skin contact, |
||||
INFLIXIMAB-DYYB, |
||||
| 342 | 26482208 |
US |
||
Incorrect dose administered, Device use error, Device malfunction, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 343 | 26482239 |
US |
||
Drug dose omission by device, Product use in unapproved indication, Device malfunction, |
||||
OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE, |
||||
| 344 | 26482300 |
US |
||
Epistaxis, Product use in unapproved indication, Product use issue, Device delivery system issue, Device malfunction, Wrong technique in device usage process, Product tampering, Wrong technique in product usage process, |
||||
OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE, OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE, |
||||
| 345 | 26482345 |
US |
2 | |
Accidental exposure to product, Product dose omission issue, Needle issue, Device malfunction, |
||||
SECUKINUMAB, SECUKINUMAB, |
||||
| 346 | 26482399 |
US |
||
Device malfunction, No adverse event, Device malfunction, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 347 | 26482429 |
US |
||
Drug dose omission by device, Product use in unapproved indication, Wrong technique in device usage process, Product tampering, Device delivery system issue, Device occlusion, Device malfunction, Circumstance or information capable of leading to medication error, |
||||
OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE, |
||||
| 348 | 26482471 |
US |
||
Device malfunction, No adverse event, Device malfunction, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 349 | 26482656 |
US |
||
Device malfunction, No adverse event, Device malfunction, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 350 | 26482719 |
US |
||
Product use in unapproved indication, Drug dose omission by device, Device delivery system issue, Device malfunction, |
||||
OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE, VARENICLINE, |
||||
| 351 | 26482740 |
US |
||
Incorrect dose administered, Device malfunction, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 352 | 26482816 |
US |
||
Product use issue, Device delivery system issue, Device malfunction, |
||||
OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE, |
||||
| 353 | 26482819 |
US |
||
Device malfunction, Product dose omission issue, |
||||
GUSELKUMAB, GUSELKUMAB, GUSELKUMAB, GUSELKUMAB, |
||||
| 354 | 26482927 |
US |
||
Drug dose omission by device, Product use issue, Device mechanical issue, Device delivery system issue, Device malfunction, |
||||
OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, |
||||
| 355 | 26482967 |
US |
||
Device malfunction, Accidental exposure to product, Exposure via skin contact, |
||||
INFLIXIMAB-DYYB, |
||||
| 356 | 26482999 |
US |
||
Product use in unapproved indication, Drug dose omission by device, Device malfunction, Device delivery system issue, |
||||
OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE, |
||||
| 357 | 26483471 |
US |
55 | |
Device malfunction, Accidental exposure to product, Exposure via skin contact, |
||||
INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, |
||||
| 358 | 26483806 |
US |
84 | 1 |
Device malfunction, Accidental exposure to product, Underdose, No adverse event, Device defective, Product complaint, |
||||
TOCILIZUMAB, |
||||
| 359 | 26483868 |
US |
42 | 2 |
Injection site bruising, Device malfunction, Wrong technique in product usage process, Device deployment issue, |
||||
FREMANEZUMAB-VFRM, |
||||
| 360 | 26483920 |
US |
87 | 2 |
Device malfunction, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, |
||||
| 361 | 26485098 |
US |
79 | |
Injection site pain, Device malfunction, Product dose omission issue, |
||||
INFLIXIMAB-DYYB, |
||||
| 362 | 26485199 |
US |
||
Asthma, Wrong technique in product usage process, Device information output issue, Device malfunction, Drug dose omission by device, |
||||
ALBUTEROL SULFATE, |
||||
| 363 | 26485200 |
US |
46 | 2 |
Incorrect dose administered by device, Device malfunction, Accidental exposure to product, Device leakage, |
||||
SECUKINUMAB, |
||||
| 364 | 26485253 |
US |
18 | |
Device malfunction, Abdominal discomfort, Malaise, Pyrexia, Accidental exposure to product, Exposure via skin contact, Product dose omission in error, Wrong technique in product usage process, |
||||
INFLIXIMAB-DYYB, |
||||
| 365 | 26475942 |
US |
62 | 2 |
Device malfunction, Device leakage, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, |
||||
| 366 | 26476079 |
US |
||
Device malfunction, |
||||
PEGFILGRASTIM, |
||||
| 367 | 26476109 |
US |
11 | |
Device malfunction, Drug dose omission by device, Product dose omission issue, |
||||
ADALIMUMAB-AATY, ADALIMUMAB-AATY, |
||||
| 368 | 26476137 |
US |
82 | |
Device malfunction, Accidental exposure to product, Exposure via skin contact, |
||||
ADALIMUMAB-AATY, ADALIMUMAB-AATY, DULAGLUTIDE, |
||||
| 369 | 26476155 |
US |
1 | |
Product dose omission issue, Device malfunction, |
||||
| 370 | 26476250 |
US |
74 | |
Injection site pain, Device malfunction, Exposure via skin contact, Accidental exposure to product, |
||||
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, METHOTREXATE, METHOTREXATE SODIUM, |
||||
| 371 | 26476299 |
US |
60 | |
Device malfunction, Drug dose omission by device, Exposure via skin contact, Accidental exposure to product, Product use issue, |
||||
ADALIMUMAB-AATY, ADALIMUMAB-AATY, |
||||
| 372 | 26476304 |
US |
80 | |
Device malfunction, Drug dose omission by device, |
||||
ADALIMUMAB-AATY, ADALIMUMAB-AATY, |
||||
| 373 | 26476320 |
US |
75 | |
Drug dose omission by device, Device malfunction, Exposure via skin contact, |
||||
ADALIMUMAB-AATY, ADALIMUMAB-AATY, |
||||
| 374 | 26476358 |
US |
62 | |
Off label use, Device malfunction, Device delivery system issue, Device deposit issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 375 | 26476369 |
US |
||
Device malfunction, Exposure via skin contact, Accidental exposure to product, |
||||
ADALIMUMAB-AATY, ADALIMUMAB-AATY, |
||||
| 376 | 26476398 |
US |
67 | |
Device malfunction, Accidental exposure to product, Exposure via skin contact, |
||||
ADALIMUMAB-AATY, ADALIMUMAB-AATY, |
||||
| 377 | 26476414 |
US |
29 | 2 |
Injection site discharge, Device malfunction, Product dose omission issue, Device leakage, |
||||
VEDOLIZUMAB, VEDOLIZUMAB, |
||||
| 378 | 26476456 |
US |
53 | |
Condition aggravated, Device malfunction, Drug dose omission by device, |
||||
ADALIMUMAB-AATY, ADALIMUMAB-AATY, |
||||
| 379 | 26476474 |
US |
||
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 380 | 26476498 |
US |
61 | |
Arthritis, Device malfunction, Accidental exposure to product, Exposure via skin contact, Drug dose omission by device, |
||||
ADALIMUMAB-AATY, ADALIMUMAB-AATY, |
||||
| 381 | 26476524 |
US |
30 | |
Device malfunction, Drug dose omission by device, |
||||
ADALIMUMAB-AATY, ADALIMUMAB-AATY, |
||||
| 382 | 26476566 |
BR |
1 | |
Asthmatic crisis, Device malfunction, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 383 | 26476587 |
US |
64 | |
Device malfunction, Drug dose omission by device, Therapy interrupted, |
||||
ADALIMUMAB-AATY, ADALIMUMAB-AATY, ADALIMUMAB-AATY, ADALIMUMAB-AATY, ADALIMUMAB-AATY, METOPROLOL TARTRATE, METOPROLOL, TRIAMTERENE CAPSULES, TRIAMTERENE, |
||||
| 384 | 26476622 |
US |
41 | |
Device malfunction, Exposure via skin contact, Accidental exposure to product, Wrong technique in product usage process, |
||||
ADALIMUMAB-AATY, ADALIMUMAB-AATY, |
||||
| 385 | 26476643 |
US |
35 | |
Device malfunction, Drug dose omission by device, Wrong technique in product usage process, Accidental exposure to product, Exposure via skin contact, |
||||
ADALIMUMAB-AATY, ADALIMUMAB-AATY, |
||||
| 386 | 26476839 |
39 | 1 | |
Psoriasis, Product dose omission issue, Device malfunction, |
||||
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB-RYVK, ADALIMUMAB-RYVK, |
||||
| 387 | 26476927 |
US |
52 | |
Device malfunction, Drug dose omission by device, |
||||
ADALIMUMAB-AATY, ADALIMUMAB-AATY, AZATHIOPRINE, |
||||
| 388 | 26476969 |
US |
68 | |
Device malfunction, Drug dose omission by device, |
||||
ADALIMUMAB-AATY, ADALIMUMAB-AATY, |
||||
| 389 | 26477014 |
US |
||
Injection site haemorrhage, Injection site pain, Incorrect dose administered, Device malfunction, Off label use, Intentional overdose, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 390 | 26477080 |
CA |
51 | |
Device malfunction, Exposure via skin contact, Accidental exposure to product, Drug dose omission by device, Intentional product use issue, |
||||
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, |
||||
| 391 | 26477105 |
US |
63 | |
Device malfunction, Drug dose omission by device, Wrong technique in product usage process, Intentional product use issue, |
||||
ADALIMUMAB-AATY, ADALIMUMAB-AATY, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, FOLIC ACID, METHOTREXATE, METHOTREXATE SODIUM, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, |
||||
| 392 | 26477129 |
US |
16 | |
Device malfunction, Exposure via skin contact, Accidental exposure to product, |
||||
ADALIMUMAB-AATY, ADALIMUMAB-AATY, |
||||
| 393 | 26477169 |
US |
||
Device malfunction, |
||||
NITRIC OXIDE, |
||||
| 394 | 26477176 |
US |
||
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 395 | 26477258 |
US |
||
Pruritus, Device malfunction, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 396 | 26477558 |
US |
28 | |
Device malfunction, Drug dose omission by device, |
||||
INFLIXIMAB-DYYB, |
||||
| 397 | 26477627 |
US |
39 | |
Device malfunction, Injection site pain, Injection site reaction, Drug dose omission by device, |
||||
INFLIXIMAB-DYYB, CETIRIZINE HYDROCHLORIDE, ERGOCALCIFEROL, |
||||
| 398 | 26477877 |
US |
32 | |
Device malfunction, Incorrect dose administered by device, |
||||
INFLIXIMAB-DYYB, |
||||
| 399 | 26477944 |
US |
1 | |
Device malfunction, Device leakage, Accidental exposure to product, Incorrect dose administered by device, Injection site discomfort, |
||||
SECUKINUMAB, |
||||
| 400 | 26477989 |
US |
54 | |
Device malfunction, Drug dose omission by device, |
||||
ADALIMUMAB-AATY, ADALIMUMAB-AATY, |
||||
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
2026-04-28