Drug:
Reaction: DEVICE BREAKAGE
20260101 - 20261231
No. 501 - 600
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 501 | 26326415 |
US |
2 | |
Device breakage, No adverse event, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 502 | 26326416 |
US |
49 | 2 |
Vulvovaginal pain, Vaginal haemorrhage, Device breakage, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 503 | 26326420 |
US |
2 | |
Device breakage, Product substitution issue, No adverse event, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 504 | 26326427 |
US |
||
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 505 | 26326429 |
US |
2 | |
Device breakage, No adverse event, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 506 | 26326434 |
US |
27 | 2 |
Vulvovaginal discomfort, Vulvovaginal pain, Device breakage, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 507 | 26326435 |
US |
2 | |
Device breakage, No adverse event, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 508 | 26326437 |
US |
2 | |
Device breakage, No adverse event, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 509 | 26326441 |
US |
2 | |
Device breakage, No adverse event, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 510 | 26326442 |
US |
42 | 2 |
Vulvovaginal pruritus, Vulvovaginal pain, Vulvovaginal discomfort, Device breakage, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 511 | 26326444 |
US |
2 | |
Medical device site pain, Device breakage, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 512 | 26326445 |
US |
2 | |
Vulvovaginal discomfort, Vulvovaginal pain, Device breakage, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 513 | 26326446 |
US |
2 | |
Vulvovaginal pruritus, Vulvovaginal pain, Device breakage, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 514 | 26326447 |
US |
41 | 2 |
Vulvovaginal discomfort, Device breakage, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 515 | 26326448 |
US |
2 | |
Device breakage, No adverse event, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 516 | 26326450 |
US |
24 | 2 |
Vulvovaginal pain, Vulvovaginal discomfort, Device breakage, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 517 | 26326451 |
US |
2 | |
Vulvovaginal injury, Vulvovaginal discomfort, Device breakage, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 518 | 26326467 |
US |
2 | |
Device breakage, No adverse event, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 519 | 26326473 |
US |
44 | 2 |
Vulvovaginal injury, Feeling abnormal, Vulvovaginal pain, Vulvovaginal discomfort, Device breakage, Product substitution issue, |
||||
ETONOGESTREL AND ETHINYL ESTRADIOL, ETONOGESTREL AND ETHINYL ESTRADIOL, ETONOGESTREL AND ETHINYL ESTRADIOL, |
||||
| 520 | 26328911 |
US |
1 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 521 | 26328928 |
US |
1 | |
Device use issue, Device breakage, |
||||
SOMATROPIN, |
||||
| 522 | 26329272 |
US |
||
Accidental exposure to product, Exposure via skin contact, Device issue, Device breakage, Suspected product contamination, |
||||
LOTILANER OPHTHALMIC SOLUTION, LEVOTHYROXINE SODIUM, LISINOPRIL, |
||||
| 523 | 26329381 |
US |
||
Eye irritation, Device breakage, Accidental exposure to product, |
||||
LOTILANER OPHTHALMIC SOLUTION, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, |
||||
| 524 | 26329427 |
US |
||
Therapy interrupted, Device breakage, Device leakage, |
||||
LOTILANER OPHTHALMIC SOLUTION, |
||||
| 525 | 26329727 |
US |
11 | 1 |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 526 | 26329770 |
US |
2 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 527 | 26319572 |
US |
1 | |
Poor quality device used, Device breakage, |
||||
SOMATROPIN, |
||||
| 528 | 26320383 |
US |
||
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 529 | 26320646 |
US |
1 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 530 | 26320774 |
US |
2 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 531 | 26320778 |
US |
2 | |
Circumstance or information capable of leading to medication error, Off label use, Device breakage, |
||||
SOMATROPIN, |
||||
| 532 | 26321160 |
US |
41 | 2 |
Device breakage, Foreign body in reproductive tract, Complication of device removal, Embedded device, Emotional distress, Abnormal uterine bleeding, Discomfort, Abdominal pain, Pyrexia, Muscle spasms, |
||||
COPPER, |
||||
| 533 | 26321201 |
US |
||
Device breakage, |
||||
| 534 | 26321334 |
US |
1 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 535 | 26321735 |
US |
||
Drug dose omission by device, Device breakage, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 536 | 26321982 |
US |
||
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 537 | 26322660 |
30 | 2 | |
Device breakage, Embedded device, Complication of device removal, |
||||
LEVONORGESTREL, |
||||
| 538 | 26322819 |
US |
53 | 2 |
Poor quality device used, Device breakage, Device issue, Headache, Hot flush, |
||||
ESTRADIOL, ESTRADIOL, CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE, |
||||
| 539 | 26323447 |
GB |
15 | 2 |
Drug dose omission by device, Device breakage, Device use error, |
||||
SOMATROPIN, |
||||
| 540 | 26323467 |
US |
12 | 2 |
Device use error, Device breakage, Device issue, |
||||
SOMATROPIN, |
||||
| 541 | 26323553 |
US |
10 | 1 |
Device breakage, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 542 | 26324500 |
US |
2 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 543 | 26312349 |
US |
1 | |
Drug dose omission by device, Device breakage, |
||||
SOMATROPIN, |
||||
| 544 | 26312575 |
US |
2 | |
Circumstance or information capable of leading to device use error, Device breakage, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 545 | 26312791 |
US |
11 | 2 |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 546 | 26314224 |
US |
||
Device breakage, |
||||
| 547 | 26314230 |
US |
||
Device breakage, |
||||
| 548 | 26315501 |
US |
2 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 549 | 26315639 |
US |
32 | 1 |
Drug dose omission by device, Device breakage, Device mechanical issue, |
||||
SOMATROPIN, |
||||
| 550 | 26315676 |
US |
18 | 1 |
Drug dose omission by device, Device material issue, Device breakage, Device dislocation, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 551 | 26316865 |
KR |
10 | 2 |
Drug dose omission by device, Device leakage, Device breakage, Liquid product physical issue, |
||||
SOMATROPIN, |
||||
| 552 | 26316983 |
CO |
1 | |
Device mechanical issue, Device breakage, |
||||
SOMATROPIN, |
||||
| 553 | 26317078 |
US |
1 | |
Device failure, Device delivery system issue, Device breakage, |
||||
MARSTACIMAB-HNCQ, MARSTACIMAB-HNCQ, |
||||
| 554 | 26317079 |
EU |
10 | 1 |
Drug dose omission by device, Device mechanical issue, Device breakage, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 555 | 26317080 |
US |
7 | 1 |
Device breakage, |
||||
SOMATROPIN, SOMATROPIN, SOMATROPIN, |
||||
| 556 | 26317623 |
US |
2 | 2 |
Device breakage, |
||||
SOMATROPIN, |
||||
| 557 | 26317800 |
51 | 2 | |
Embedded device, Device breakage, Device expulsion, Complication of device removal, Device use issue, |
||||
LEVONORGESTREL, |
||||
| 558 | 26318301 |
US |
7 | 2 |
Device breakage, Off label use, |
||||
SOMATROPIN, |
||||
| 559 | 26318542 |
US |
||
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 560 | 26319100 |
EU |
77 | 2 |
Shoulder fracture, Device dislocation, Device breakage, Incorrect route of product administration, |
||||
LEVODOPA, ENTACAPONE, |
||||
| 561 | 26307428 |
US |
1 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 562 | 26308301 |
US |
2 | |
Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Anxiety, Pain, |
||||
COPPER, |
||||
| 563 | 26308303 |
US |
2 | |
Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Pain, |
||||
COPPER, |
||||
| 564 | 26308304 |
US |
49 | 2 |
Device breakage, Foreign body in urogenital tract, Complication of device removal, Emotional distress, Uterine spasm, Uterine inflammation, Pollakiuria, Bladder discomfort, Muscle spasms, Discomfort, Pain, |
||||
COPPER, FLUTICASONE PROPIONATE, ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL, ALPRAZOLAM, CETIRIZINE HYDROCHLORIDE, |
||||
| 565 | 26308728 |
US |
||
Intercepted product preparation error, Off label use, Device breakage, Device leakage, |
||||
LEUPROLIDE ACETATE, |
||||
| 566 | 26309434 |
US |
2 | |
Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Anxiety, Pain, Device use issue, Off label use, |
||||
COPPER, |
||||
| 567 | 26309897 |
KR |
||
Device breakage, Device use error, |
||||
SOMATROPIN, |
||||
| 568 | 26309909 |
US |
6 | 1 |
Drug dose omission by device, Device information output issue, Device physical property issue, Device delivery system issue, Device breakage, |
||||
SOMATROPIN, |
||||
| 569 | 26309927 |
US |
15 | 1 |
Device use error, Device use issue, Device breakage, |
||||
SOMATROPIN, |
||||
| 570 | 26309936 |
CL |
11 | 2 |
Device breakage, |
||||
SOMATROPIN, |
||||
| 571 | 26310308 |
US |
18 | 1 |
Drug dose omission by device, Device breakage, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 572 | 26310310 |
CO |
2 | |
Device breakage, Device information output issue, Device use error, Incorrect dose administered by device, |
||||
SOMATROPIN, |
||||
| 573 | 26311293 |
US |
1 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 574 | 26312306 |
US |
1 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 575 | 26304233 |
CA |
2 | |
Facial operation, Catheter site bruise, Catheter site nodule, Catheter site related reaction, Device breakage, Dyskinesia, On and off phenomenon, Post procedural discomfort, |
||||
FOSCARBIDOPA/FOSLEVODOPA, FOSCARBIDOPA/FOSLEVODOPA, FOSCARBIDOPA/FOSLEVODOPA, ENTACAPONE, CARBIDOPA AND LEVODOPA, AMANTADINE, MIRABEGRON, CLONAZEPAM, CARBIDOPA AND LEVODOPA, POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL (3350), POLYETHYLENE GLYCOL 400, INSTALAX POLYETHYLENE GLYCOL 3350, ERGOCALCIFEROL, MELATONIN, |
||||
| 576 | 26305263 |
US |
32 | 2 |
Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Embedded device, Emotional distress, Anxiety, Pain, |
||||
COPPER, ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITSLOPRAM, MAGNESIUM, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, CALCIUM CARBONATE, |
||||
| 577 | 26305468 |
US |
34 | 2 |
Reproductive complication associated with device, Device breakage, Foreign body in urogenital tract, Complication of device removal, Abortion spontaneous, Emotional distress, |
||||
COPPER, |
||||
| 578 | 26305700 |
40 | 2 | |
Uterine perforation, Embedded device, Device breakage, Device difficult to use, Complication of device removal, |
||||
LEVONORGESTREL, |
||||
| 579 | 26305865 |
US |
15 | 2 |
Drug dose omission by device, Device use error, Device breakage, Device mechanical issue, |
||||
SOMATROPIN, |
||||
| 580 | 26305899 |
GB |
34 | 1 |
Drug dose omission by device, Device information output issue, Device breakage, |
||||
SOMATROPIN, |
||||
| 581 | 26305962 |
CO |
1 | |
Drug dose omission by device, Device mechanical issue, Device breakage, Device defective, |
||||
SOMATROPIN, |
||||
| 582 | 26306061 |
2 | ||
Device breakage, Complication of device insertion, |
||||
LEVONORGESTREL, |
||||
| 583 | 26306842 |
US |
71 | 2 |
Device breakage, |
||||
ESTRADIOL, |
||||
| 584 | 26301971 |
US |
14 | 1 |
Device breakage, |
||||
SOMATROPIN, |
||||
| 585 | 26301972 |
US |
16 | 1 |
Device breakage, |
||||
SOMATROPIN, |
||||
| 586 | 26301974 |
US |
21 | 1 |
Device breakage, |
||||
SOMATROPIN, |
||||
| 587 | 26302015 |
KR |
10 | |
Device breakage, Device material issue, |
||||
SOMATROPIN, |
||||
| 588 | 26302022 |
US |
10 | 2 |
Device breakage, |
||||
SOMATROPIN, |
||||
| 589 | 26302157 |
US |
1 | |
Poor quality device used, Device breakage, |
||||
SOMATROPIN, |
||||
| 590 | 26302667 |
EU |
79 | 2 |
Tracheostomy, Device breakage, |
||||
| 591 | 26298372 |
US |
1 | |
Fall, Device breakage, Device dislocation, |
||||
FOSCARBIDOPA/FOSLEVODOPA, |
||||
| 592 | 26299022 |
US |
2 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 593 | 26299086 |
US |
2 | |
Injury, Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Emotional distress, Pain, |
||||
COPPER, |
||||
| 594 | 26299087 |
US |
2 | |
Injury, Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Emotional distress, Pain, |
||||
COPPER, |
||||
| 595 | 26299088 |
US |
2 | |
Injury, Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Emotional distress, Pain, |
||||
COPPER, |
||||
| 596 | 26299090 |
US |
2 | |
Injury, Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Emotional distress, Pain, |
||||
COPPER, |
||||
| 597 | 26299091 |
US |
2 | |
Injury, Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Emotional distress, Pain, |
||||
COPPER, |
||||
| 598 | 26299092 |
US |
2 | |
Injury, Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Emotional distress, Pain, |
||||
COPPER, |
||||
| 599 | 26299178 |
US |
2 | |
Injury, Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Emotional distress, Pain, |
||||
COPPER, |
||||
| 600 | 26299179 |
US |
2 | |
Injury, Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Emotional distress, Pain, |
||||
COPPER, |
||||
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