Drug:
Reaction: DRUG DOSE OMISSION BY DEVICE
20250101 - 20251231
No. 401 - 500
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 401 | 25089029 |
US |
8 | 1 |
Wrong technique in device usage process, Device breakage, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 402 | 25089033 |
US |
13 | 1 |
Drug dose omission by device, Device use error, |
||||
SOMATROPIN, |
||||
| 403 | 25089081 |
US |
14 | 1 |
Drug dose omission by device, Device physical property issue, |
||||
SOMATROPIN, |
||||
| 404 | 25089083 |
US |
13 | 1 |
Device breakage, Device information output issue, Device physical property issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 405 | 25089084 |
US |
18 | 1 |
Drug dose omission by device, Device mechanical issue, Device connection issue, |
||||
SOMATROPIN, |
||||
| 406 | 25089085 |
US |
30 | 1 |
Device mechanical issue, Device leakage, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 407 | 25089086 |
US |
11 | 1 |
Drug dose omission by device, Poor quality device used, Device leakage, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 408 | 25089089 |
US |
46 | 2 |
Drug dose omission by device, Device delivery system issue, Device mechanical issue, Device physical property issue, |
||||
SOMATROPIN, |
||||
| 409 | 25089111 |
US |
64 | 2 |
Unintentional medical device removal, Drug dose omission by device, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, |
||||
| 410 | 25089126 |
US |
11 | 1 |
Drug dose omission by device, Device mechanical issue, Device breakage, |
||||
SOMATROPIN, BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 411 | 25089143 |
PR |
13 | 1 |
Device information output issue, Device mechanical issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 412 | 25089169 |
TR |
38 | 1 |
Device failure, Drug dose omission by device, |
||||
ETANERCEPT, |
||||
| 413 | 25089174 |
US |
14 | 2 |
Device information output issue, Device mechanical issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 414 | 25089391 |
US |
66 | 2 |
Accidental exposure to product, Injection site haemorrhage, Drug dose omission by device, Wrong technique in product usage process, |
||||
EVOLOCUMAB, |
||||
| 415 | 25089714 |
US |
||
Dyspnoea, Drug dose omission by device, Device delivery system issue, Product packaging quantity issue, Device malfunction, Product quality issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, |
||||
| 416 | 25089951 |
IT |
13 | 1 |
Drug dose omission by device, Device mechanical issue, |
||||
SOMATROPIN, |
||||
| 417 | 25089962 |
US |
73 | 1 |
Device malfunction, Drug dose omission by device, |
||||
PEGFILGRASTIM, |
||||
| 418 | 25090012 |
IT |
0 | 1 |
Device mechanical issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 419 | 25090071 |
US |
74 | |
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, |
||||
| 420 | 25090257 |
US |
73 | 1 |
Deafness, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, |
||||
| 421 | 25090419 |
US |
81 | 2 |
COVID-19 pneumonia, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 422 | 25090576 |
CN |
||
Coronary artery bypass, Stent placement, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, |
||||
| 423 | 25090895 |
US |
2 | |
Drug dose omission by device, Device malfunction, |
||||
ADALIMUMAB, ADALIMUMAB-FKJP, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB, ADALIMUMAB-FKJP, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, |
||||
| 424 | 25091055 |
US |
13 | 1 |
Drug dose omission by device, Device breakage, |
||||
SOMATROPIN, SOMATROPIN, SOMATROPIN, SOMATROPIN, |
||||
| 425 | 25091950 |
US |
72 | 2 |
Device difficult to use, Drug dose omission by device, Abdominal pain upper, Wrong technique in product usage process, |
||||
EVOLOCUMAB, |
||||
| 426 | 25092037 |
US |
1 | |
Drug dose omission by device, Device mechanical issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 427 | 25081817 |
IT |
11 | 1 |
Therapy interrupted, Drug dose omission by device, Device mechanical issue, |
||||
SOMATROPIN, |
||||
| 428 | 25082018 |
US |
||
Illness, Drug dose omission by device, Product packaging quantity issue, Device delivery system issue, Device mechanical issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 429 | 25082067 |
US |
57 | 2 |
Device difficult to use, Drug dose omission by device, Product communication issue, Injection site pain, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 430 | 25082068 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 431 | 25082293 |
IT |
16 | 1 |
Drug dose omission by device, Device mechanical issue, |
||||
SOMATROPIN, |
||||
| 432 | 25082383 |
US |
81 | 2 |
Injection site bruising, Device difficult to use, Drug dose omission by device, Cough, |
||||
EVOLOCUMAB, NIACIN, |
||||
| 433 | 25082597 |
US |
82 | 2 |
Hypoacusis, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, |
||||
| 434 | 25082749 |
IT |
54 | 2 |
Drug dose omission by device, Device occlusion, Device issue, |
||||
SOMATROPIN, |
||||
| 435 | 25083364 |
US |
78 | 2 |
Pain in extremity, Drug dose omission by device, Device difficult to use, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 436 | 25083369 |
CA |
53 | 2 |
Colitis ulcerative, Symptom recurrence, Cholecystectomy, Frequent bowel movements, Product availability issue, Device use confusion, Drug dose omission by device, Off label use, |
||||
ADALIMUMAB-ADAZ, ADALIMUMAB-ADAZ, ADALIMUMAB-ADAZ, ADALIMUMAB-ADAZ, CITALOPRAM, CITALOPRAM HYDROBROMIDE, CLONAZEPAM, IRBESARTAN, LEVOTHYROXINE SODIUM, |
||||
| 437 | 25083462 |
US |
89 | 2 |
Surgery, Drug dose omission by device, Device difficult to use, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 438 | 25083465 |
US |
37 | 1 |
Device information output issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 439 | 25083660 |
US |
||
Device delivery system issue, Drug dose omission by device, No adverse event, |
||||
LEVALBUTEROL TARTRATE, LEVALBUTEROL TARTRATE, |
||||
| 440 | 25083782 |
US |
75 | 1 |
Viral infection, Drug dose omission by device, Device difficult to use, Device use error, |
||||
ERENUMAB-AOOE, |
||||
| 441 | 25083934 |
US |
||
Drug dose omission by device, Wrong technique in product usage process, Product use in unapproved indication, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 442 | 25083966 |
US |
71 | |
Dyspnoea, Drug dose omission by device, Wrong technique in device usage process, Device malfunction, Off label use, |
||||
ALBUTEROL SULFATE, |
||||
| 443 | 25083977 |
US |
61 | |
Drug dose omission by device, Wrong technique in product usage process, Device malfunction, No adverse event, |
||||
ALBUTEROL SULFATE, BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 444 | 25083993 |
US |
70 | |
Device delivery system issue, Drug dose omission by device, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 445 | 25084030 |
US |
77 | |
Dyspnoea, Loss of personal independence in daily activities, Off label use, Wrong technique in product usage process, Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 446 | 25084307 |
GB |
27 | 2 |
Product preparation issue, Product deposit, Device difficult to use, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 447 | 25084328 |
KR |
12 | 2 |
Drug dose omission by device, Device leakage, Device physical property issue, |
||||
SOMATROPIN, |
||||
| 448 | 25084377 |
US |
10 | 1 |
Drug dose omission by device, Device leakage, Device mechanical issue, |
||||
SOMATROPIN, |
||||
| 449 | 25084378 |
US |
12 | 1 |
Device information output issue, Poor quality device used, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 450 | 25084381 |
US |
6 | 1 |
Device physical property issue, Device use error, Device breakage, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 451 | 25084393 |
US |
12 | 1 |
Drug dose omission by device, Device breakage, Device mechanical issue, |
||||
SOMATROPIN, |
||||
| 452 | 25084395 |
US |
7 | 2 |
Device mechanical issue, Drug dose omission by device, Product dispensing error, |
||||
SOMATROPIN, |
||||
| 453 | 25084400 |
US |
15 | 1 |
Drug dose omission by device, Device use error, |
||||
SOMATROPIN, |
||||
| 454 | 25085010 |
US |
71 | |
Dyspnoea, Drug dose omission by device, Wrong technique in product usage process, |
||||
ALBUTEROL SULFATE, BACLOFEN, MIRTAZAPINE, METOPROLOL SUCCINATE, ESCITALOPRAM, ATORVASTATIN CALCIUM, GABAPENTIN, POTASSIUM CHLORIDE, POTASSIUM CHLORIDE EXTENDED-RELEASE, POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE, POTASSIUM CHLORIDE ORAL, |
||||
| 455 | 25085382 |
US |
||
Drug dose omission by device, Device delivery system issue, No adverse event, |
||||
LEVALBUTEROL TARTRATE, LEVALBUTEROL TARTRATE, LEVALBUTEROL TARTRATE, |
||||
| 456 | 25085572 |
US |
60 | 2 |
Thinking abnormal, Migraine, Accidental exposure to product, Drug dose omission by device, Wrong technique in product usage process, Injury associated with device, Therapy partial responder, Constipation, |
||||
ERENUMAB-AOOE, ERENUMAB-AOOE, UBROGEPANT, |
||||
| 457 | 25085697 |
CO |
1 | |
Device occlusion, Drug dose omission by device, Wrong technique in product usage process, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 458 | 25086016 |
US |
73 | 2 |
Accidental exposure to product, Device difficult to use, Drug dose omission by device, Injection site pain, |
||||
EVOLOCUMAB, |
||||
| 459 | 25080381 |
US |
2 | |
Drug dose omission by device, Device breakage, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 460 | 25080460 |
US |
85 | 2 |
Drug dose omission by device, Device difficult to use, |
||||
EVOLOCUMAB, |
||||
| 461 | 25080522 |
US |
66 | 2 |
Device difficult to use, Accidental exposure to product, Drug dose omission by device, Injection site haemorrhage, |
||||
EVOLOCUMAB, EVOLOCUMAB, EVOLOCUMAB, |
||||
| 462 | 25080676 |
US |
69 | 2 |
Device difficult to use, Intentional product misuse, Drug dose omission by device, Venous operation, Wrong technique in product usage process, Injection site bruising, Injection site pain, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 463 | 25080767 |
US |
31 | 2 |
Device difficult to use, Drug dose omission by device, Product communication issue, Injection site pain, |
||||
ERENUMAB-AOOE, |
||||
| 464 | 25080783 |
US |
76 | 1 |
Blood cholesterol increased, Device difficult to use, Product preparation error, Drug dose omission by device, Wrong technique in product usage process, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 465 | 25080802 |
US |
51 | 2 |
Accidental exposure to product, Wrong technique in product usage process, Injury associated with device, Drug dose omission by device, |
||||
ERENUMAB-AOOE, ERENUMAB-AOOE, |
||||
| 466 | 25080848 |
US |
77 | 1 |
Injection site bruising, Injection site haemorrhage, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, |
||||
| 467 | 25081171 |
JP |
||
Drug dose omission by device, No adverse event, Device delivery system issue, |
||||
GLUCAGON, DIPYRIDAMOLE, PAROXETINE HYDROCHLORIDE, INSULIN LISPRO, ROSUVASTATIN, |
||||
| 468 | 25076878 |
US |
83 | 1 |
Hypoacusis, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 469 | 25076888 |
US |
82 | |
Drug dose omission by device, Device leakage, Symptom recurrence, |
||||
TEZEPELUMAB-EKKO, |
||||
| 470 | 25076917 |
US |
83 | 2 |
Limb operation, Synovial rupture, Drug dose omission by device, Device difficult to use, Influenza, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 471 | 25077099 |
US |
2 | |
Hypersensitivity, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 472 | 25077117 |
US |
78 | 2 |
Neuropathy peripheral, Blood pressure increased, Chest discomfort, Eye swelling, Myalgia, Pruritus, Back pain, Headache, Fatigue, Diarrhoea, Urinary tract infection, Gait disturbance, Arthralgia, Device difficult to use, Drug dose omission by device, Device use error, Wrong technique in product usage process, |
||||
EVOLOCUMAB, EVOLOCUMAB, GABAPENTIN, GABAPENTIN, |
||||
| 473 | 25077138 |
US |
||
Drug dose omission by device, Product leakage, |
||||
INFLIXIMAB-DYYB, |
||||
| 474 | 25077139 |
US |
78 | 2 |
Cerebrovascular accident, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, APIXABAN, |
||||
| 475 | 25077301 |
US |
||
Drug dose omission by device, Device delivery system issue, Device mechanical issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 476 | 25077302 |
US |
||
Drug dose omission by device, Device delivery system issue, Device mechanical issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 477 | 25077418 |
US |
79 | 2 |
Injection site pain, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, ADALIMUMAB, |
||||
| 478 | 25077449 |
US |
||
Device malfunction, Drug dose omission by device, |
||||
INFLIXIMAB-DYYB, |
||||
| 479 | 25077583 |
US |
22 | |
Injection site pain, Accidental exposure to product, Device difficult to use, Drug dose omission by device, Wrong technique in product usage process, |
||||
ERENUMAB-AOOE, |
||||
| 480 | 25077768 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 481 | 25077782 |
US |
||
Drug dose omission by device, Device delivery system issue, Product substitution issue, Device mechanical issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 482 | 25077794 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 483 | 25077879 |
US |
||
Incorrect dose administered by device, Drug dose omission by device, Visual impairment, Device malfunction, Device delivery system issue, |
||||
EXENATIDE, |
||||
| 484 | 25077976 |
US |
38 | 2 |
Cough, Asthma, Injection site pain, COVID-19, Sneezing, Injection site haemorrhage, Accidental exposure to product, Device difficult to use, Drug dose omission by device, Device use error, |
||||
ERENUMAB-AOOE, |
||||
| 485 | 25078021 |
US |
||
Device malfunction, Illness, Drug dose omission by device, |
||||
INFLIXIMAB-DYYB, |
||||
| 486 | 25078116 |
US |
85 | 2 |
Cerebrovascular accident, Device difficult to use, Drug dose omission by device, Musculoskeletal disorder, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 487 | 25078120 |
US |
1 | |
Device delivery system issue, Drug dose omission by device, |
||||
PEGFILGRASTIM, |
||||
| 488 | 25078545 |
US |
||
Drug dose omission by device, Expired product administered, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 489 | 25078552 |
US |
||
Drug dose omission by device, Device breakage, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 490 | 25078580 |
US |
2 | |
Device issue, Accidental exposure to product, Drug dose omission by device, Device leakage, |
||||
SECUKINUMAB, CLINDAMYCIN PHOSPHATE, CLINDAMYCIN, |
||||
| 491 | 25078581 |
US |
59 | 1 |
Fear of injection, Device difficult to use, Drug dose omission by device, |
||||
ERENUMAB-AOOE, |
||||
| 492 | 25078999 |
US |
14 | 1 |
Drug dose omission by device, Device physical property issue, Device information output issue, Device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 493 | 25079022 |
GB |
8 | 2 |
Drug dose omission by device, Device information output issue, Device power source issue, |
||||
SOMATROPIN, |
||||
| 494 | 25079028 |
US |
14 | 1 |
Device mechanical issue, Device delivery system issue, Device leakage, Drug dose omission by device, |
||||
SOMATROPIN, SOMATROPIN, SOMATROPIN, |
||||
| 495 | 25079030 |
US |
||
Drug dose omission by device, Device mechanical issue, Device physical property issue, |
||||
SOMATROPIN, |
||||
| 496 | 25079035 |
US |
8 | 1 |
Device mechanical issue, Device leakage, Drug dose omission by device, Poor quality device used, |
||||
SOMATROPIN, |
||||
| 497 | 25079041 |
GR |
12 | 2 |
Device physical property issue, Poor quality device used, Drug dose omission by device, Device use error, |
||||
SOMATROPIN, |
||||
| 498 | 25079047 |
US |
11 | 1 |
Device leakage, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 499 | 25079050 |
US |
8 | 1 |
Drug dose omission by device, Device delivery system issue, |
||||
SOMATROPIN, |
||||
| 500 | 25079069 |
US |
66 | 2 |
Device difficult to use, Drug dose omission by device, Product communication issue, Product dispensing issue, Accidental exposure to product, Injection site pain, Wrong technique in product usage process, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
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.
terms
license
last_updated
2025-04-28