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 | 26888370 |
US |
30 | |
Device malfunction, Product dose omission issue, Intentional product use issue, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 302 | 26888390 |
US |
81 | |
Product dose omission issue, Device malfunction, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 303 | 26888706 |
US |
||
Device malfunction, Device leakage, Drug dose omission by device, Unevaluable event, Injection site discharge, |
||||
| 304 | 26888811 |
US |
39 | |
Device malfunction, Incorrect dose administered, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 305 | 26888965 |
US |
2 | |
Device malfunction, Device deployment issue, Injury associated with device, Incorrect dose administered by device, |
||||
SECUKINUMAB, |
||||
| 306 | 26888990 |
US |
||
No adverse event, Device malfunction, Device malfunction, No adverse event, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 307 | 26889049 |
US |
57 | 2 |
Device malfunction, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, |
||||
| 308 | 26889132 |
US |
74 | 2 |
Device malfunction, Needle issue, |
||||
SECUKINUMAB, |
||||
| 309 | 26889514 |
US |
2 | |
Chest discomfort, Asthma, Product use issue, Device use error, Inappropriate schedule of product administration, Device malfunction, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 310 | 26889684 |
US |
2 | |
Product substitution issue, Product dose omission issue, Device malfunction, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE, |
||||
| 311 | 26889924 |
US |
50 | 2 |
Device malfunction, Inappropriate schedule of product administration, |
||||
GUSELKUMAB, |
||||
| 312 | 26890502 |
US |
1 | |
Device malfunction, Product dose omission issue, |
||||
GUSELKUMAB, GUSELKUMAB, GUSELKUMAB, GUSELKUMAB, |
||||
| 313 | 26890855 |
US |
54 | 2 |
Colitis ulcerative, Malaise, Device malfunction, Product leakage, Incorrect dose administered, Off label use, Therapeutic response decreased, |
||||
GUSELKUMAB, GUSELKUMAB, |
||||
| 314 | 26890859 |
US |
16 | |
Product dose omission issue, Device malfunction, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 315 | 26891425 |
US |
64 | 2 |
Dyspnoea, Device malfunction, Product dose omission issue, |
||||
| 316 | 26891471 |
US |
1 | |
Device malfunction, Drug dose omission by device, |
||||
| 317 | 26891472 |
US |
86 | 2 |
Device malfunction, Injection site haemorrhage, |
||||
| 318 | 26891473 |
US |
2 | |
Injection site haemorrhage, Device malfunction, Drug dose omission by device, |
||||
| 319 | 26891474 |
US |
74 | 1 |
Device malfunction, Incorrect dose administered by product, Wrong technique in product usage process, |
||||
ORAL SEMAGLUTIDE, ORAL SEMAGLUTIDE, |
||||
| 320 | 26891475 |
US |
26 | 2 |
Drug dose omission by device, Device malfunction, |
||||
| 321 | 26891478 |
US |
2 | |
Injection site pain, Injection site discharge, Device malfunction, Accidental exposure to product, |
||||
| 322 | 26891479 |
US |
2 | |
Accidental exposure to product, Device malfunction, Device leakage, Product dose omission issue, |
||||
| 323 | 26891480 |
US |
2 | |
Injection site bruising, Dysgeusia, Device malfunction, Incorrect dose administered by device, |
||||
| 324 | 26891799 |
US |
79 | 2 |
Device malfunction, No adverse event, |
||||
VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, LOTILANER OPHTHALMIC SOLUTION, |
||||
| 325 | 26881231 |
US |
1 | |
Scratch, Device leakage, Drug dose omission by device, Device malfunction, |
||||
| 326 | 26881315 |
US |
2 | |
Drug dose omission by device, Night sweats, Device malfunction, |
||||
| 327 | 26881316 |
US |
69 | 2 |
Weight loss poor, Device malfunction, Injection site discharge, |
||||
| 328 | 26881328 |
US |
2 | |
Device defective, Device malfunction, Device leakage, |
||||
SECUKINUMAB, |
||||
| 329 | 26881331 |
US |
2 | |
Renal failure, Device malfunction, |
||||
| 330 | 26881453 |
US |
55 | |
Haematological infection, Sepsis, Off label use, Device malfunction, Circumstance or information capable of leading to medication error, |
||||
ALBUTEROL SULFATE AND BUDESONIDE, |
||||
| 331 | 26881486 |
US |
70 | 2 |
Product dose omission issue, Device malfunction, |
||||
ALBUTEROL SULFATE AND BUDESONIDE, |
||||
| 332 | 26881832 |
CN |
62 | 1 |
Product packaging quantity issue, Device malfunction, Incorrect dose administered by device, Asthma, Drug resistance, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 333 | 26882064 |
US |
2 | |
Drug dose omission by device, Device malfunction, Device leakage, Device mechanical issue, No adverse event, |
||||
LIRAGLUTIDE, |
||||
| 334 | 26882067 |
US |
25 | |
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 335 | 26882149 |
US |
94 | 2 |
Device malfunction, Product administration issue, Intentional product use issue, Incorrect dose administered, Memory impairment, |
||||
BENRALIZUMAB, BENRALIZUMAB, |
||||
| 336 | 26882340 |
US |
||
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 337 | 26882406 |
US |
2 | |
Incorrect dose administered by device, Product use issue, Product dose omission issue, Device use issue, Device malfunction, |
||||
ALBUTEROL SULFATE AND BUDESONIDE, |
||||
| 338 | 26883342 |
US |
81 | 2 |
Device malfunction, Device malfunction, Injection site erythema, Product dose omission issue, Off label use, |
||||
| 339 | 26884001 |
US |
76 | 2 |
Hunger, Incorrect dose administered by device, Device malfunction, Device leakage, |
||||
| 340 | 26884004 |
US |
1 | |
Vision blurred, Product dose omission issue, Device malfunction, Blood glucose increased, |
||||
ORAL SEMAGLUTIDE, ORAL SEMAGLUTIDE, |
||||
| 341 | 26884065 |
US |
2 | |
Blood glucose increased, Drug dose omission by device, Device malfunction, |
||||
| 342 | 26884152 |
US |
56 | |
Injection site haemorrhage, Device malfunction, Malaise, Injection site haemorrhage, |
||||
| 343 | 26884357 |
US |
36 | 2 |
Device malfunction, Device mechanical issue, |
||||
SOMATROPIN, |
||||
| 344 | 26884442 |
US |
37 | |
Device malfunction, Accidental exposure to product, Exposure via skin contact, Drug dose omission by device, |
||||
INFLIXIMAB-DYYB, |
||||
| 345 | 26884494 |
US |
25 | |
Device malfunction, Exposure via skin contact, Accidental exposure to product, |
||||
INFLIXIMAB-DYYB, |
||||
| 346 | 26884497 |
US |
||
Migraine, Device malfunction, Injection site rash, |
||||
FREMANEZUMAB-VFRM, |
||||
| 347 | 26884513 |
US |
||
Incorrect dose administered, Device malfunction, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 348 | 26884537 |
US |
46 | 1 |
Product dose omission issue, Incorrect dose administered, Device malfunction, |
||||
BIMEKIZUMAB, |
||||
| 349 | 26884634 |
US |
||
Dyspnoea, Off label use, Device delivery system issue, Device malfunction, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALBUTEROL SULFATE, BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 350 | 26884732 |
US |
35 | 2 |
Device issue, Product dose omission issue, Device malfunction, |
||||
GUSELKUMAB, GUSELKUMAB, |
||||
| 351 | 26884756 |
US |
20 | 2 |
No adverse event, Device malfunction, |
||||
VEDOLIZUMAB, |
||||
| 352 | 26884781 |
US |
59 | |
Device malfunction, Drug dose omission by device, |
||||
INFLIXIMAB-DYYB, |
||||
| 353 | 26885176 |
US |
||
Needle track marks, Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 354 | 26885285 |
US |
36 | |
Product dose omission issue, Device malfunction, |
||||
NEMOLIZUMAB-ILTO, FLUOXETINE HYDROCHLORIDE, |
||||
| 355 | 26886242 |
US |
36 | 2 |
Drug dose omission by device, Device leakage, Device malfunction, |
||||
| 356 | 26886243 |
US |
41 | 2 |
Wrong technique in device usage process, Accidental exposure to product, Device malfunction, Device leakage, |
||||
| 357 | 26886244 |
US |
2 | |
Incorrect dose administered by device, Device malfunction, Device leakage, |
||||
| 358 | 26886247 |
US |
60 | 2 |
Product dose omission issue, Device malfunction, Product use in unapproved indication, |
||||
ORAL SEMAGLUTIDE, |
||||
| 359 | 26886248 |
US |
2 | |
Accidental exposure to product, Product dose omission issue, Device malfunction, |
||||
| 360 | 26886249 |
US |
||
Product dose omission issue, Device malfunction, |
||||
ORAL SEMAGLUTIDE, |
||||
| 361 | 26886251 |
US |
2 | |
Drug dose omission by device, Device malfunction, Injection site discharge, |
||||
| 362 | 26886253 |
US |
58 | 2 |
Drug dose omission by device, Device malfunction, Phobia, Device leakage, Product colour issue, |
||||
| 363 | 26886254 |
US |
||
Product dose omission issue, Device malfunction, Device leakage, |
||||
| 364 | 26886255 |
US |
||
Injection site discharge, Device malfunction, |
||||
| 365 | 26886256 |
US |
||
Drug dose omission by device, Device malfunction, |
||||
| 366 | 26886257 |
US |
2 | |
Drug dose omission by device, Device malfunction, Accidental exposure to product, |
||||
| 367 | 26886262 |
US |
||
Drug dose omission by device, Device malfunction, |
||||
| 368 | 26886263 |
US |
58 | |
Accidental exposure to product, Device malfunction, Device leakage, |
||||
| 369 | 26886264 |
US |
53 | 2 |
Contusion, Device malfunction, |
||||
| 370 | 26886265 |
US |
||
Drug dose omission by device, Device malfunction, |
||||
| 371 | 26886266 |
US |
2 | |
Incorrect dose administered by device, Device malfunction, |
||||
ORAL SEMAGLUTIDE, |
||||
| 372 | 26886268 |
US |
2 | |
Injection site discomfort, Injection site discharge, Device malfunction, |
||||
| 373 | 26886269 |
US |
79 | 1 |
Device malfunction, Incorrect dose administered by device, Device leakage, |
||||
| 374 | 26886482 |
US |
||
Device malfunction, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
| 375 | 26876077 |
US |
||
Device malfunction, Product leakage, Inappropriate schedule of product administration, |
||||
INFLIXIMAB, INFLIXIMAB, |
||||
| 376 | 26876689 |
US |
59 | |
Illness, Device malfunction, |
||||
ORAL SEMAGLUTIDE, |
||||
| 377 | 26876718 |
US |
||
Incorrect dose administered, Device malfunction, |
||||
RISPERIDONE, |
||||
| 378 | 26876846 |
US |
48 | 2 |
Device malfunction, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, |
||||
| 379 | 26876921 |
US |
63 | 2 |
Ehlers-Danlos syndrome, Device malfunction, Nausea, Wrong technique in device usage process, Muscular weakness, Typical aura without headache, Malaise, Incorrect dose administered, Arthritis, |
||||
FREMANEZUMAB-VFRM, FREMANEZUMAB-VFRM, |
||||
| 380 | 26876999 |
US |
46 | 2 |
Contusion, Device malfunction, |
||||
| 381 | 26877187 |
US |
72 | 2 |
Increased appetite, Device malfunction, Product dose omission issue, |
||||
| 382 | 26877417 |
US |
70 | 2 |
Device malfunction, Injection site haemorrhage, Device leakage, Needle track marks, |
||||
| 383 | 26877513 |
US |
53 | |
Device malfunction, Anxiety, |
||||
| 384 | 26877516 |
US |
17 | |
Device malfunction, Incorrect dose administered by device, Injection site haemorrhage, Eye irritation, |
||||
| 385 | 26877527 |
US |
31 | |
Incorrect dose administered by device, Increased appetite, Device malfunction, |
||||
| 386 | 26878076 |
US |
2 | |
Device issue, Device malfunction, Device mechanical issue, Product quality issue, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE, BUDESONIDE AND FORMOTEROL FUMARATE, BUDESONIDE AND FORMOTEROL FUMARATE, BUDESONIDE AND FORMOTEROL FUMARATE, |
||||
| 387 | 26878125 |
US |
33 | |
Device malfunction, Exposure via skin contact, Accidental exposure to product, |
||||
INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, |
||||
| 388 | 26878275 |
US |
||
Device malfunction, Incorrect dose administered by device, |
||||
INFLIXIMAB-DYYB, |
||||
| 389 | 26878362 |
US |
88 | 2 |
Device malfunction, Product temperature excursion issue, Amnesia, |
||||
ORAL SEMAGLUTIDE, |
||||
| 390 | 26878409 |
US |
38 | 2 |
Injection site indentation, Hunger, Drug dose omission by device, Device malfunction, Device leakage, |
||||
| 391 | 26879010 |
US |
2 | |
Drug ineffective, Device malfunction, |
||||
FREMANEZUMAB-VFRM, |
||||
| 392 | 26879787 |
55 | ||
Device delivery system issue, Device malfunction, |
||||
SUMATRIPTAN, SUMATRIPTAN SUCCINATE, SUMATRIPTAN, SUMATRIPTAN SUCCINATE, |
||||
| 393 | 26879826 |
US |
12 | 1 |
Device malfunction, Device delivery system issue, Device issue, |
||||
SOMATROPIN, |
||||
| 394 | 26879832 |
US |
20 | |
Device malfunction, Exposure via skin contact, Accidental exposure to product, |
||||
INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITSLOPRAM, ATOMOXETINE, PROGESTERONE, |
||||
| 395 | 26879909 |
US |
2 | |
Product dose omission issue, Device malfunction, Device use error, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 396 | 26879978 |
US |
1 | |
Lung disorder, Product dose omission issue, Device malfunction, Device use error, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 397 | 26880046 |
US |
84 | 2 |
Product dose omission issue, Device malfunction, No adverse event, Product dose omission issue, Device malfunction, |
||||
OMALIZUMAB, OMALIZUMAB, |
||||
| 398 | 26880104 |
US |
2 | |
Device use issue, Incorrect dose administered by device, Product storage issue, Device malfunction, Product contamination physical, Device delivery system issue, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 399 | 26880144 |
US |
1 | |
Product use issue, Wrong technique in device usage process, Device delivery system issue, Device malfunction, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE, |
||||
| 400 | 26880329 |
US |
71 | |
Device malfunction, Extra dose administered, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
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
2026-07-30