Drug:
Reaction: DEVICE BREAKAGE
20260101 - 20261231
No. 301 - 400
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 301 | 26369311 |
US |
||
Airway burns, Device breakage, Incorrect dose administered, |
||||
PORFIMER SODIUM, |
||||
| 302 | 26369683 |
US |
||
Device breakage, No adverse event, |
||||
LEVALBUTEROL TARTRATE, |
||||
| 303 | 26370794 |
US |
15 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 304 | 26370916 |
US |
43 | 2 |
Uterine leiomyoma, Haemorrhagic ovarian cyst, Device breakage, Foreign body in reproductive tract, Complication of device removal, Embedded device, Pelvic inflammatory disease, Uterine adhesions, Uterine inflammation, Vulvovaginal pain, Uterine scar, Post procedural diarrhoea, Abdominal pain lower, Pelvic pain, Pelvic discomfort, Heavy menstrual bleeding, Back pain, Abdominal pain, Device use issue, Off label use, Device dislocation, |
||||
COPPER, |
||||
| 305 | 26371242 |
US |
15 | 1 |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 306 | 26372294 |
US |
2 | |
Device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 307 | 26372684 |
US |
11 | 1 |
Device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 308 | 26373203 |
US |
1 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 309 | 26373410 |
US |
24 | 2 |
High risk pregnancy, Abortion spontaneous, Pregnancy with contraceptive device, Drug ineffective, Device breakage, Foreign body in reproductive tract, Complication of device removal, Emotional distress, |
||||
COPPER, |
||||
| 310 | 26373784 |
US |
1 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 311 | 26364197 |
US |
10 | 1 |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 312 | 26364359 |
US |
1 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 313 | 26364563 |
US |
1 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 314 | 26364629 |
US |
57 | 2 |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
GLATIRAMER ACETATE, GLATIRAMER ACETATE, |
||||
| 315 | 26364730 |
US |
1 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 316 | 26365233 |
US |
46 | 2 |
Hysterectomy, Salpingo-oophorectomy bilateral, Device breakage, Foreign body in reproductive tract, Complication of device removal, Embedded device, Procedural haemorrhage, Anxiety, Emotional distress, |
||||
COPPER, FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE, LEVOTHYROXINE SODIUM, VALSARTAN, VALSARTAN ORAL, |
||||
| 317 | 26365337 |
US |
1 | |
Product dose omission issue, Device breakage, |
||||
SOMATROPIN, |
||||
| 318 | 26365965 |
16 | 2 | |
Device breakage, Complication of device insertion, |
||||
LEVONORGESTREL, |
||||
| 319 | 26366062 |
47 | 2 | |
Device breakage, Device physical property issue, Complication of device insertion, |
||||
LEVONORGESTREL, |
||||
| 320 | 26366553 |
US |
||
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 321 | 26366606 |
US |
2 | |
Injury associated with device, Accidental exposure to product, Device breakage, |
||||
| 322 | 26366639 |
US |
||
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 323 | 26366748 |
US |
||
Drug dose omission by device, Device breakage, Device difficult to use, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 324 | 26366963 |
US |
4 | 1 |
Respiratory disorder, Dialysis, Device breakage, Device mechanical issue, |
||||
SOMATROPIN, SOMATROPIN, SOMATROPIN, |
||||
| 325 | 26366966 |
GB |
51 | 2 |
Drug dose omission by device, Device issue, Device material issue, Device breakage, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 326 | 26367159 |
PA |
18 | 1 |
Device information output issue, Drug dose omission by device, Device breakage, |
||||
SOMATROPIN, |
||||
| 327 | 26367420 |
US |
1 | |
Device breakage, Circumstance or information capable of leading to device use error, |
||||
SOMATROPIN, |
||||
| 328 | 26367463 |
US |
2 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 329 | 26367657 |
US |
11 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 330 | 26368238 |
US |
14 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 331 | 26368243 |
US |
11 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 332 | 26368244 |
US |
16 | 1 |
Product dose omission issue, Device breakage, |
||||
SOMATROPIN, |
||||
| 333 | 26368272 |
US |
1 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 334 | 26363987 |
US |
41 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 335 | 26364071 |
US |
1 | |
Device use issue, Device breakage, Device mechanical issue, |
||||
SOMATROPIN, |
||||
| 336 | 26362234 |
US |
67 | 1 |
Blood glucose increased, Injection site pain, Device breakage, |
||||
INSULIN GLARGINE, INSULIN GLARGINE, |
||||
| 337 | 26357682 |
US |
||
Injury associated with device, Device safety feature issue, Device breakage, Syringe issue, Device failure, |
||||
ENOXAPARIN SODIUM, |
||||
| 338 | 26357716 |
JP |
||
Device maintenance issue, Incorrect dose administered by device, Device breakage, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 339 | 26357753 |
US |
2 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 340 | 26358082 |
US |
1 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 341 | 26358108 |
US |
1 | |
Wrong technique in product usage process, Incorrect dose administered by device, Circumstance or information capable of leading to medication error, Device breakage, Device issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 342 | 26358830 |
US |
||
Intercepted product preparation error, Device breakage, Device leakage, |
||||
LEUPROLIDE ACETATE, |
||||
| 343 | 26358883 |
US |
||
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 344 | 26358889 |
US |
2 | |
Device breakage, Foreign body in reproductive tract, Complication of device removal, Embedded device, Procedural pain, Psychological trauma, Emotional distress, Vulvovaginal burning sensation, Vulvovaginal pruritus, Device expulsion, Pain, Menometrorrhagia, Discomfort, Pelvic pain, Vaginal discharge, |
||||
COPPER, |
||||
| 345 | 26359192 |
US |
1 | |
Circumstance or information capable of leading to medication error, Device breakage, Device malfunction, |
||||
SOMATROPIN, |
||||
| 346 | 26359273 |
US |
||
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 347 | 26359353 |
US |
1 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 348 | 26359723 |
US |
12 | 1 |
Product storage error, Product dose omission issue, Device breakage, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 349 | 26360229 |
US |
1 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 350 | 26360729 |
US |
13 | 2 |
Device breakage, |
||||
SOMATROPIN, |
||||
| 351 | 26360732 |
US |
3 | 2 |
Drug dose omission by device, Device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 352 | 26360822 |
2 | ||
Device breakage, |
||||
LEVONORGESTREL, |
||||
| 353 | 26361390 |
US |
||
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 354 | 26361487 |
US |
1 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 355 | 26361497 |
US |
47 | 1 |
Drug dose omission by device, Device use error, Device breakage, Device physical property issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 356 | 26361673 |
US |
1 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 357 | 26362061 |
EU |
2 | |
Device breakage, Drug dose omission by device, Hypoglycaemia, |
||||
| 358 | 26350992 |
US |
2 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 359 | 26351025 |
US |
12 | 1 |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 360 | 26352550 |
US |
||
Intercepted product preparation error, Device breakage, Device leakage, |
||||
LEUPROLIDE ACETATE, |
||||
| 361 | 26352613 |
US |
67 | |
Device breakage, |
||||
TEZEPELUMAB-EKKO, TEZEPELUMAB-EKKO, |
||||
| 362 | 26352691 |
US |
2 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 363 | 26353166 |
US |
1 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 364 | 26353391 |
US |
1 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 365 | 26353885 |
US |
||
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 366 | 26353992 |
US |
||
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 367 | 26354031 |
US |
1 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 368 | 26354160 |
US |
||
Drug ineffective, Device breakage, Device delivery system issue, |
||||
ALBUTEROL SULFATE, |
||||
| 369 | 26354417 |
US |
||
Device breakage, Accidental exposure to product, |
||||
| 370 | 26354811 |
US |
1 | |
Fear of injection, Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 371 | 26354960 |
AR |
9 | 1 |
Product dose omission in error, Device physical property issue, Device delivery system issue, Device breakage, |
||||
SOMATROPIN, |
||||
| 372 | 26355000 |
CO |
2 | |
Device breakage, |
||||
SOMATROPIN, |
||||
| 373 | 26355225 |
US |
1 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 374 | 26355226 |
US |
1 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 375 | 26355962 |
US |
2 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 376 | 26356176 |
US |
2 | |
Drug dose omission by device, Device breakage, |
||||
SOMATROPIN, |
||||
| 377 | 26356177 |
US |
1 | |
Product use complaint, Device leakage, Device breakage, |
||||
SOMATROPIN, |
||||
| 378 | 26356178 |
US |
1 | |
Drug dose omission by device, Wrong technique in device usage process, Device breakage, Device issue, |
||||
ALBUTEROL SULFATE, |
||||
| 379 | 26343938 |
US |
1 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 380 | 26343958 |
US |
2 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 381 | 26344198 |
US |
2 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 382 | 26344340 |
US |
||
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 383 | 26344531 |
US |
74 | 2 |
Product adhesion issue, Injection site pruritus, Device difficult to use, Device infusion issue, Device breakage, |
||||
TREPROSTINIL, TREPROSTINIL, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATED, DOCUSATE SODIUM, DOCUSATE SODIUM 100MG, METOCLOPRAMIDE HYDROCHLORIDE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE, OXYCODONE HYDROCHLORIDE, OXYCODONE, BISACODYL, BISACODYL SUPPOSITORIES, BISCODYL, MOMETASONE FUROATE, FLUTICASONE PROPIONATE, DICLOFENAC SODIUM, DICLOFENAC SODIUM TOPICAL, DICLOFENAC SODIUM TOPICAL GEL, 1%, DICLOFENAC, DICLOFENAC SODIUM 1%, CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE OINTMENT USP, 0.05%, OXYGEN, 0XYGEN, IRON, ACETAMINOPHEN, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ALBUTEROL SULFATE, LIDOCAINE, LIDOCAINE HYDROCHLORIDE, BURN RELIEF, LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE, LIDOCAINE 4%, LIDOCAINE, MENTHOL, POLYETHYLENE GLYCOL, AMLODIPINE BESYLATE, SENNOSIDES, SENNA LEAF, SENNA, LEVALBUTEROL TARTRATE, LORAZEPAM, POTASSIUM CHLORIDE, POTASSIUM CHLORIDE EXTENDED-RELEASE, POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE, POTASSIUM CHLORIDE ORAL, |
||||
| 384 | 26344756 |
US |
48 | 2 |
Device breakage, Foreign body in reproductive tract, Complication of device removal, Anxiety, Pain, |
||||
COPPER, |
||||
| 385 | 26344757 |
US |
2 | |
Reproductive complication associated with device, Deformity, Device breakage, Foreign body in reproductive tract, Complication of device removal, Anxiety, Pain, |
||||
COPPER, |
||||
| 386 | 26344758 |
US |
2 | |
Reproductive complication associated with device, Deformity, Device breakage, Foreign body in reproductive tract, Complication of device removal, Anxiety, Pain, Device use issue, Off label use, |
||||
COPPER, |
||||
| 387 | 26344760 |
US |
2 | |
Injury, Deformity, Device breakage, Foreign body in reproductive tract, Complication of device removal, Emotional distress, |
||||
COPPER, |
||||
| 388 | 26344762 |
US |
44 | 2 |
Surgery, Device breakage, Foreign body in reproductive tract, Complication of device removal, Embedded device, Anxiety, Pain, Menstruation irregular, Intermenstrual bleeding, Device use issue, Off label use, |
||||
COPPER, ALBUTEROL SULFATE, FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE, METOPROLOL TARTRATE, METOPROLOL, AMLODIPINE, PANTOPRAZOLE, |
||||
| 389 | 26345090 |
US |
||
Wrong technique in device usage process, Expired device used, Device breakage, |
||||
SOMATROPIN, |
||||
| 390 | 26345091 |
US |
1 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 391 | 26345302 |
US |
||
Circumstance or information capable of leading to medication error, Device breakage, |
||||
ESTRADIOL, ESTRADIOL GEL 0.1%, ESTRADIOL TRANSDERMAL, ESTRADIOL,, |
||||
| 392 | 26345504 |
US |
17 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 393 | 26345662 |
US |
||
Device breakage, |
||||
| 394 | 26346021 |
US |
85 | 1 |
Haemoptysis, Device breakage, |
||||
TREPROSTINIL, TREPROSTINIL, FUROSEMIDE, FOLIC ACID, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATED, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, OXYGEN, 0XYGEN, MIDODRINE HYDROCHLORIDE, |
||||
| 395 | 26346319 |
US |
1 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 396 | 26346440 |
US |
||
Device leakage, Device breakage, |
||||
SOMATROPIN, |
||||
| 397 | 26346443 |
US |
2 | |
Drug dose omission by device, Device breakage, |
||||
SOMATROPIN, |
||||
| 398 | 26346540 |
US |
1 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 399 | 26347218 |
US |
1 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 400 | 26347448 |
US |
16 | 1 |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
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