Drug:
Reaction: DEVICE BREAKAGE
20260101 - 20261231
No. 401 - 500
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 401 | 26347899 |
US |
||
Disability, Device breakage, |
||||
CARBOXYMETHYLCELLULOSE SODIUM AND GLYCERIN, CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, |
||||
| 402 | 26347949 |
US |
1 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 403 | 26347951 |
US |
1 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 404 | 26347973 |
US |
1 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 405 | 26348016 |
US |
1 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 406 | 26337516 |
US |
1 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 407 | 26337635 |
US |
1 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 408 | 26338068 |
US |
1 | |
Device breakage, Circumstance or information capable of leading to medication error, |
||||
SOMATROPIN, |
||||
| 409 | 26338177 |
US |
63 | 1 |
Spinal operation, Device breakage, Pain, |
||||
UPADACITINIB, |
||||
| 410 | 26338584 |
US |
1 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 411 | 26338601 |
US |
1 | |
Circumstance or information capable of leading to device use error, Device mechanical issue, Device breakage, |
||||
SOMATROPIN, |
||||
| 412 | 26338637 |
US |
13 | 1 |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 413 | 26338672 |
US |
||
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 414 | 26338712 |
US |
1 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 415 | 26339060 |
US |
2 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 416 | 26339268 |
US |
1 | |
Circumstance or information capable of leading to medication error, Device breakage, Product quality issue, |
||||
SOMATROPIN, |
||||
| 417 | 26339643 |
17 | 2 | |
Device breakage, Complication of device insertion, |
||||
LEVONORGESTREL, |
||||
| 418 | 26341459 |
KR |
14 | 2 |
Drug dose omission by device, Device use error, Device mechanical issue, Device breakage, Device information output issue, |
||||
SOMATROPIN, |
||||
| 419 | 26341858 |
US |
13 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 420 | 26342049 |
US |
1 | |
Circumstance or information capable of leading to medication error, Device breakage, Device issue, |
||||
SOMATROPIN, |
||||
| 421 | 26342139 |
US |
1 | |
Incorrect dose administered by device, Device breakage, |
||||
SOMATROPIN, |
||||
| 422 | 26332427 |
US |
71 | 2 |
Product use issue, Device breakage, |
||||
ROPEGINTERFERON ALFA-2B, ROPEGINTERFERON ALFA-2B, ROPEGINTERFERON ALFA-2B, ROPEGINTERFERON ALFA-2B, ROPEGINTERFERON ALFA-2B, ROPEGINTERFERON ALFA-2B, ROPEGINTERFERON ALFA-2B, |
||||
| 423 | 26332851 |
US |
16 | 1 |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 424 | 26333372 |
US |
||
Drug dose omission by device, Device breakage, Product packaging quantity issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 425 | 26334027 |
US |
14 | 1 |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 426 | 26334187 |
US |
||
Device breakage, |
||||
| 427 | 26334189 |
US |
||
Device breakage, |
||||
| 428 | 26334190 |
US |
||
Device breakage, |
||||
| 429 | 26334191 |
US |
||
Device breakage, |
||||
| 430 | 26334362 |
US |
2 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 431 | 26334933 |
US |
1 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 432 | 26335232 |
US |
1 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 433 | 26335519 |
US |
1 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 434 | 26335864 |
US |
2 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 435 | 26335949 |
PR |
15 | 1 |
Drug dose omission by device, Device issue, Device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 436 | 26335954 |
US |
||
Device breakage, Device leakage, |
||||
SOMATROPIN, |
||||
| 437 | 26335955 |
US |
1 | |
Drug dose omission by device, Device breakage, |
||||
SOMATROPIN, |
||||
| 438 | 26336339 |
US |
17 | 1 |
Device breakage, Device mechanical issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 439 | 26336341 |
KR |
10 | 2 |
Drug dose omission by device, Device breakage, Device material issue, Product prescribing error, |
||||
SOMATROPIN, |
||||
| 440 | 26336350 |
US |
11 | 1 |
Device issue, Device mechanical issue, Device breakage, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 441 | 26336440 |
US |
6 | 1 |
Device deployment issue, Device breakage, |
||||
SOMATROPIN, |
||||
| 442 | 26336441 |
US |
12 | 1 |
Drug dose omission by device, Device use error, Device mechanical issue, Device breakage, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 443 | 26336451 |
EU |
17 | 1 |
Drug dose omission by device, Device mechanical issue, Device breakage, |
||||
SOMATROPIN, |
||||
| 444 | 26336487 |
US |
1 | 2 |
Device use error, Device breakage, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 445 | 26330201 |
US |
||
Device breakage, Accidental exposure to product, Exposure via skin contact, Off label use, |
||||
LOTILANER OPHTHALMIC SOLUTION, LOTILANER OPHTHALMIC SOLUTION, LOTILANER OPHTHALMIC SOLUTION, ALLOPURINOL, AMLODIPINE, LOSARTAN, HYDROCHLOROTHIAZIDE, ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITSLOPRAM, |
||||
| 446 | 26330277 |
US |
||
Device breakage, Product container seal issue, Poor quality device used, |
||||
LOTILANER OPHTHALMIC SOLUTION, NAPROXEN SODIUM, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, GUAIFENESIN, ERGOCALCIFEROL, MAGNESIUM, LOSARTAN, TAFLUPROST, LEVOTHYROXINE SODIUM, |
||||
| 447 | 26330279 |
US |
||
Skin irritation, Device breakage, Accidental exposure to product, Exposure via skin contact, Product use issue, Product prescribing issue, |
||||
LOTILANER OPHTHALMIC SOLUTION, MIRTAZAPINE, VONOPRAZAN FUMARATE, TENAPANOR HYDROCHLORIDE, LAMOTRIGINE, GABAPENTIN, ATOGEPANT, SUMATRIPTAN, SUMATRIPTAN SUCCINATE, BUDESONIDE, |
||||
| 448 | 26330672 |
US |
2 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 449 | 26331079 |
US |
||
Eye pain, Device breakage, Product odour abnormal, Suspected product contamination, Therapy interrupted, |
||||
LOTILANER OPHTHALMIC SOLUTION, |
||||
| 450 | 26331081 |
US |
||
Device breakage, Wrong technique in product usage process, Therapy interrupted, |
||||
LOTILANER OPHTHALMIC SOLUTION, |
||||
| 451 | 26331554 |
US |
1 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 452 | 26324665 |
US |
2 | |
Device malfunction, Device breakage, Device delivery system issue, |
||||
SUMATRIPTAN SUCCINATE, |
||||
| 453 | 26324739 |
US |
2 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 454 | 26324745 |
US |
16 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 455 | 26324760 |
US |
8 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 456 | 26324787 |
US |
2 | |
Dyspnoea, Incorrect dose administered by device, Product use issue, Wrong technique in device usage process, Device delivery system issue, Product dose omission issue, Device breakage, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 457 | 26325391 |
US |
2 | |
Malaise, Chest pain, Drug dose omission by device, Device leakage, Device breakage, Hypertension, |
||||
SUMATRIPTAN SUCCINATE, |
||||
| 458 | 26326008 |
US |
||
Therapy interrupted, Off label use, Device breakage, |
||||
LOTILANER OPHTHALMIC SOLUTION, |
||||
| 459 | 26326059 |
US |
1 | |
Circumstance or information capable of leading to device use error, Device use issue, Device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 460 | 26326343 |
US |
||
Application site pain, Device breakage, Product substitution issue, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 461 | 26326350 |
US |
2 | |
Device breakage, No adverse event, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 462 | 26326351 |
US |
2 | |
Device breakage, No adverse event, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 463 | 26326352 |
US |
49 | 2 |
Medical device site discomfort, Device breakage, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 464 | 26326354 |
US |
2 | |
Device breakage, No adverse event, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 465 | 26326355 |
US |
2 | |
Device breakage, No adverse event, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 466 | 26326356 |
US |
2 | |
Device breakage, No adverse event, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 467 | 26326358 |
US |
2 | |
Device breakage, No adverse event, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 468 | 26326360 |
US |
2 | |
Application site irritation, Device breakage, No adverse event, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 469 | 26326361 |
US |
2 | |
Device breakage, No adverse event, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 470 | 26326362 |
US |
36 | 2 |
Vaginal haemorrhage, Device breakage, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 471 | 26326364 |
US |
2 | |
Device breakage, No adverse event, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 472 | 26326365 |
US |
2 | |
Device breakage, No adverse event, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 473 | 26326366 |
US |
2 | |
Device breakage, No adverse event, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 474 | 26326368 |
US |
2 | |
Application site injury, Haemorrhage, Device breakage, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 475 | 26326369 |
US |
2 | |
Device breakage, No adverse event, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 476 | 26326370 |
US |
2 | |
Device breakage, No adverse event, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 477 | 26326371 |
US |
2 | |
Device breakage, No adverse event, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 478 | 26326372 |
US |
2 | |
Device breakage, No adverse event, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 479 | 26326374 |
US |
2 | |
Device breakage, No adverse event, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 480 | 26326376 |
US |
2 | |
Device breakage, No adverse event, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 481 | 26326377 |
US |
2 | |
Device breakage, No adverse event, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 482 | 26326378 |
US |
2 | |
Device breakage, No adverse event, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 483 | 26326379 |
US |
2 | |
Device breakage, No adverse event, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 484 | 26326389 |
US |
||
Device breakage, No adverse event, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 485 | 26326390 |
US |
2 | |
Device breakage, No adverse event, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 486 | 26326391 |
US |
2 | |
Device breakage, No adverse event, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 487 | 26326392 |
US |
2 | |
Device breakage, No adverse event, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 488 | 26326393 |
US |
2 | |
Device breakage, No adverse event, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 489 | 26326394 |
US |
2 | |
Device breakage, No adverse event, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 490 | 26326396 |
US |
2 | |
Medical device site discomfort, Device breakage, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 491 | 26326397 |
US |
2 | |
Device breakage, No adverse event, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 492 | 26326399 |
US |
21 | 2 |
Medical device site pain, Device breakage, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, ETONOGESTREL AND ETHINYL ESTRADIOL, ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 493 | 26326400 |
US |
2 | |
Device breakage, No adverse event, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 494 | 26326401 |
US |
2 | |
Device breakage, No adverse event, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 495 | 26326402 |
US |
2 | |
Device breakage, No adverse event, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 496 | 26326403 |
US |
2 | |
Cervix injury, Vulvovaginal injury, Product substitution issue, Device breakage, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 497 | 26326405 |
US |
26 | 2 |
Vulvovaginal pain, Device breakage, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 498 | 26326412 |
US |
19 | 2 |
Vulvovaginal pain, Device breakage, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 499 | 26326413 |
US |
2 | |
Device breakage, No adverse event, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 500 | 26326414 |
US |
||
Vulvovaginal discomfort, Device breakage, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
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