Drug:
Reaction: DRUG DOSE OMISSION BY DEVICE
20250101 - 20251231
No. 501 - 600
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 501 | 25079148 |
AU |
67 | 1 |
Dementia, Drug dose omission by device, Device difficult to use, Device issue, Device leakage, |
||||
FREMANEZUMAB-VFRM, FREMANEZUMAB-VFRM, |
||||
| 502 | 25079286 |
US |
2 | |
Device malfunction, Accidental exposure to product, Exposure via skin contact, Device leakage, Drug dose omission by device, |
||||
SECUKINUMAB, |
||||
| 503 | 25079434 |
US |
86 | 2 |
Tremor, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, |
||||
| 504 | 25079745 |
US |
84 | 2 |
Ventricular extrasystoles, Device difficult to use, Wrong technique in product usage process, Accidental exposure to product, Drug dose omission by device, |
||||
ERENUMAB-AOOE, |
||||
| 505 | 25079870 |
US |
28 | 2 |
Device difficult to use, Drug dose omission by device, Injection site pain, |
||||
ERENUMAB-AOOE, |
||||
| 506 | 25080279 |
US |
2 | |
Device difficult to use, Accidental exposure to product, Injection site reaction, Drug dose omission by device, |
||||
ERENUMAB-AOOE, |
||||
| 507 | 25071596 |
US |
2 | |
Injection site pain, Device adhesion issue, Drug dose omission by device, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, |
||||
| 508 | 25071625 |
US |
74 | 1 |
Constipation, Drug dose omission by device, Device difficult to use, Migraine, Wrong technique in product usage process, Therapy interrupted, |
||||
ERENUMAB-AOOE, ERENUMAB-AOOE, |
||||
| 509 | 25071634 |
US |
71 | 2 |
Injection site reaction, Injection site erythema, Injection site pruritus, Drug dose omission by device, Device difficult to use, Wrong technique in product usage process, |
||||
ETANERCEPT, |
||||
| 510 | 25071679 |
US |
71 | 1 |
Injection site pain, Accidental exposure to product, Device difficult to use, Injection site injury, Injection site haemorrhage, Drug dose omission by device, |
||||
EVOLOCUMAB, |
||||
| 511 | 25071707 |
US |
65 | 2 |
Device difficult to use, Wrong technique in product usage process, Ill-defined disorder, Drug dose omission by device, |
||||
ERENUMAB-AOOE, |
||||
| 512 | 25071891 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 513 | 25071893 |
GR |
14 | 2 |
Drug dose omission by device, Device mechanical issue, |
||||
SOMATROPIN, |
||||
| 514 | 25071924 |
US |
1 | |
Loss of consciousness, Head injury, Chest pain, Respiratory disorder, Haemorrhage, Blood pressure decreased, Body temperature decreased, Dyspnoea, Haemoptysis, Device leakage, Drug dose omission by device, |
||||
AMIKACIN, |
||||
| 515 | 25071954 |
US |
||
Blindness, Device use issue, Drug dose omission by device, Device delivery system issue, |
||||
ROFLUMILAST, |
||||
| 516 | 25072235 |
US |
||
Oxygen therapy, Drug dose omission by device, Wrong technique in product usage process, |
||||
ALBUTEROL SULFATE, |
||||
| 517 | 25072279 |
US |
||
Drug dose omission by device, Device delivery system issue, Product packaging quantity issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 518 | 25072280 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 519 | 25072453 |
US |
||
Drug dose omission by device, Syringe issue, Needle issue, Device issue, |
||||
LANREOTIDE ACETATE, |
||||
| 520 | 25072455 |
US |
||
Drug dose omission by device, Device issue, Product quality issue, |
||||
LANREOTIDE ACETATE, LANREOTIDE ACETATE, EMPAGLIFLOZIN, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, APIXABAN, PANTOPRAZOLE, CARVEDILOL, HYDROCHLOROTHIAZIDE, MAGNESIUM, |
||||
| 521 | 25072540 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 522 | 25072761 |
US |
1 | |
Drug dose omission by device, Device leakage, |
||||
SECUKINUMAB, ISOTRETINOIN, |
||||
| 523 | 25072774 |
US |
25 | |
Dyspnoea, Drug dose omission by device, Wrong technique in product usage process, Device deposit issue, |
||||
ALBUTEROL SULFATE, |
||||
| 524 | 25072991 |
US |
||
Drug dose omission by device, Device delivery system issue, Product quality issue, Product taste abnormal, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 525 | 25072996 |
US |
||
Drug dose omission by device, Wrong technique in product usage process, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 526 | 25073125 |
US |
77 | |
Wrong technique in product usage process, Drug dose omission by device, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 527 | 25073164 |
US |
51 | 2 |
Accidental exposure to product, Device difficult to use, Drug ineffective, Drug dose omission by device, |
||||
ERENUMAB-AOOE, ERENUMAB-AOOE, |
||||
| 528 | 25073261 |
US |
45 | |
Dyspnoea, Drug dose omission by device, Wrong technique in product usage process, Device deposit issue, |
||||
ALBUTEROL SULFATE, |
||||
| 529 | 25073280 |
US |
||
Dyspnoea, Device delivery system issue, Drug dose omission by device, Adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 530 | 25073282 |
US |
73 | 1 |
Device malfunction, Drug dose omission by device, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, |
||||
| 531 | 25073766 |
IT |
10 | 2 |
Therapy interrupted, Drug dose omission by device, Device mechanical issue, |
||||
SOMATROPIN, |
||||
| 532 | 25073823 |
US |
57 | 2 |
Device difficult to use, Illness, Respiratory disorder, Drug dose omission by device, |
||||
ETANERCEPT, ETANERCEPT, ETANERCEPT, |
||||
| 533 | 25073890 |
US |
65 | |
Drug dose omission by device, Device delivery system issue, No adverse event, |
||||
ALBUTEROL SULFATE, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, IBUPROFEN, IBUPROFEN CAPSULES 200 MG, IBUPROFEN TABLETS USP, 200MG, IBUPROFEN ORAL, IBUPROFEN 200MG, IBUPFROFEN, IBUPROFEN TABLET, FILM-COATED, IBUPROFEN 200 MG, IBUPROFEN CAPSULE, OXYGEN, 0XYGEN, |
||||
| 534 | 25073923 |
US |
32 | |
Wheezing, Drug dose omission by device, Off label use, Device deposit issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 535 | 25073997 |
US |
52 | |
Dyspnoea, Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 536 | 25074228 |
US |
||
Chest discomfort, Drug dose omission by device, Incorrect dose administered by device, Wrong technique in product usage process, Device delivery system issue, Incorrect dose administered, Device malfunction, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 537 | 25074462 |
US |
5 | |
Drug dose omission by device, Wrong technique in product usage process, Product storage error, No adverse event, |
||||
ALBUTEROL SULFATE, LORATADINE, LORATADINE ORAL, |
||||
| 538 | 25074557 |
US |
61 | 1 |
Coronary artery bypass, Intercepted product administration error, Off label use, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, EVOLOCUMAB, EVOLOCUMAB, EVOLOCUMAB, |
||||
| 539 | 25074949 |
AR |
13 | 2 |
Device physical property issue, Device information output issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 540 | 25074950 |
US |
6 | 2 |
Device deployment issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 541 | 25074993 |
US |
7 | 2 |
Drug dose omission by device, Device breakage, Device material issue, Device leakage, |
||||
SOMATROPIN, |
||||
| 542 | 25074995 |
GB |
1 | 2 |
Bronchiolitis, Drug dose omission by device, Accidental overdose, Device delivery system issue, Device malfunction, |
||||
SOMATROPIN, |
||||
| 543 | 25074997 |
US |
16 | 1 |
Device information output issue, Device delivery system issue, Device use issue, Incorrect dose administered by device, Drug dose omission by device, Product prescribing error, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 544 | 25075033 |
US |
9 | 2 |
Device information output issue, Device power source issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 545 | 25075054 |
US |
51 | 1 |
Drug dose omission by device, Device information output issue, |
||||
SOMATROPIN, |
||||
| 546 | 25075055 |
US |
14 | 1 |
Device breakage, Device leakage, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 547 | 25075056 |
US |
14 | 1 |
Drug dose omission by device, Device breakage, Device mechanical issue, Device material issue, Device delivery system issue, |
||||
SOMATROPIN, |
||||
| 548 | 25075333 |
US |
1 | 2 |
Device use error, Device breakage, Product physical issue, Device leakage, Incorrect dose administered by device, Drug dose omission by device, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 549 | 25075450 |
US |
35 | 2 |
Atypical pneumonia, Device malfunction, Needle issue, Drug dose omission by device, Illness, Enteritis, Epigastric discomfort, Injection site pain, Fatigue, Product knowledge deficit, Device leakage, |
||||
OFATUMUMAB, OFATUMUMAB, PROPRANOLOL HYDROCHLORIDE, |
||||
| 550 | 25075616 |
US |
63 | |
Drug dose omission by device, Device delivery system issue, No adverse event, |
||||
LEVALBUTEROL TARTRATE, LEVALBUTEROL TARTRATE, |
||||
| 551 | 25075646 |
US |
61 | |
Drug dose omission by device, Device delivery system issue, No adverse event, |
||||
LEVALBUTEROL TARTRATE, LEVALBUTEROL TARTRATE, LEVALBUTEROL TARTRATE, ALBUTEROL SULFATE, TIOTROPIUM BROMIDE, |
||||
| 552 | 25075670 |
US |
59 | |
Device delivery system issue, Drug dose omission by device, Product use in unapproved indication, No adverse event, |
||||
LEVALBUTEROL TARTRATE, |
||||
| 553 | 25075693 |
US |
||
Drug dose omission by device, Device delivery system issue, No adverse event, |
||||
LEVALBUTEROL TARTRATE, |
||||
| 554 | 25075733 |
US |
80 | 2 |
Drug dose omission by device, Product delivery mechanism issue, |
||||
LATANOPROST, LATANOPROST, |
||||
| 555 | 25075843 |
US |
||
Illness, Drug dose omission by device, Device delivery system issue, Device mechanical issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 556 | 25075886 |
US |
||
Device leakage, Drug dose omission by device, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 557 | 25076115 |
IT |
78 | 1 |
Drug dose omission by device, Device mechanical issue, |
||||
SOMATROPIN, |
||||
| 558 | 25076180 |
CO |
1 | |
Device information output issue, Device mechanical issue, Device power source issue, Device calibration failure, Device issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 559 | 25076634 |
US |
||
Drug dose omission by device, Product dose omission issue, Dyspnoea, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 560 | 25076832 |
US |
59 | 2 |
Device difficult to use, Accidental exposure to product, Wrong technique in product usage process, Drug dose omission by device, Injection site bruising, Injection site pain, Injection site haemorrhage, |
||||
EVOLOCUMAB, |
||||
| 561 | 25066251 |
US |
58 | 1 |
Visual impairment, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, |
||||
| 562 | 25066340 |
US |
||
Dyspnoea, Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 563 | 25066373 |
US |
||
Device malfunction, Drug dose omission by device, Incorrect dose administered, |
||||
INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, LEVOTHYROXINE, |
||||
| 564 | 25066487 |
US |
76 | 2 |
Injection site erythema, Injection site rash, Device difficult to use, Arthritis, Drug dose omission by device, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 565 | 25066521 |
US |
||
Device issue, Device malfunction, Product use issue, Drug dose omission by device, |
||||
INFLIXIMAB-DYYB, |
||||
| 566 | 25066653 |
US |
||
Wrong technique in product usage process, Exposure via skin contact, Accidental exposure to product, Drug dose omission by device, Intentional product use issue, |
||||
INFLIXIMAB-DYYB, |
||||
| 567 | 25066679 |
US |
54 | |
Dyspnoea, Device malfunction, Product lot number issue, Device deposit issue, Drug dose omission by device, Product packaging issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 568 | 25066680 |
US |
||
Device malfunction, Product physical issue, Drug dose omission by device, |
||||
INFLIXIMAB-DYYB, |
||||
| 569 | 25066686 |
US |
67 | |
Dyspnoea, Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, |
||||
| 570 | 25066707 |
US |
68 | |
Dyspnoea, Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALBUTEROL, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, FUROSEMIDE, MONTELUKAST, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, |
||||
| 571 | 25066814 |
US |
35 | |
Drug dose omission by device, Wrong technique in product usage process, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 572 | 25066853 |
US |
||
Drug dose omission by device, Device delivery system issue, Product packaging quantity issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 573 | 25066888 |
US |
||
Device malfunction, Incorrect dose administered, Drug dose omission by device, |
||||
INFLIXIMAB-DYYB, AZATHIOPRINE, |
||||
| 574 | 25066981 |
US |
||
Device malfunction, Drug dose omission by device, |
||||
INFLIXIMAB-DYYB, |
||||
| 575 | 25067052 |
US |
82 | 2 |
Device difficult to use, Drug dose omission by device, Product preparation error, |
||||
EVOLOCUMAB, |
||||
| 576 | 25067101 |
US |
27 | 1 |
Needle issue, Product use complaint, Device leakage, Accidental exposure to product, Drug dose omission by device, |
||||
SECUKINUMAB, |
||||
| 577 | 25067222 |
US |
||
Product leakage, Drug dose omission by device, |
||||
INFLIXIMAB-DYYB, |
||||
| 578 | 25067272 |
US |
||
Device malfunction, Drug dose omission by device, Wrong technique in device usage process, |
||||
INFLIXIMAB-DYYB, |
||||
| 579 | 25067550 |
CO |
2 | |
Device information output issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 580 | 25067574 |
US |
||
Drug dose omission by device, Device occlusion, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 581 | 25067575 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 582 | 25068384 |
US |
76 | 1 |
Device difficult to use, Multiple use of single-use product, Wrong technique in product usage process, Injection site haemorrhage, Drug dose omission by device, |
||||
EVOLOCUMAB, |
||||
| 583 | 25068969 |
US |
14 | 1 |
Device mechanical issue, Device delivery system issue, Device occlusion, Device leakage, Incorrect dose administered by device, Drug dose omission by device, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 584 | 25068972 |
CA |
64 | 1 |
Device leakage, Drug dose omission by device, |
||||
ADALIMUMAB-AFZB, PREDNISONE, |
||||
| 585 | 25069058 |
US |
13 | 1 |
Device mechanical issue, Device breakage, Drug dose omission by device, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 586 | 25069059 |
KR |
8 | 2 |
Drug dose omission by device, Device power source issue, Device information output issue, |
||||
SOMATROPIN, |
||||
| 587 | 25069061 |
US |
14 | 1 |
Drug dose omission by device, Device physical property issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 588 | 25069064 |
US |
26 | 1 |
Injection site discomfort, Drug dose omission by device, Device delivery system issue, Poor quality device used, Device information output issue, Device material issue, |
||||
SOMATROPIN, |
||||
| 589 | 25069070 |
US |
12 | 1 |
Device mechanical issue, Drug dose omission by device, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 590 | 25069200 |
IT |
50 | 1 |
Drug dose omission by device, Device occlusion, Device issue, |
||||
SOMATROPIN, |
||||
| 591 | 25069206 |
US |
13 | 1 |
Drug dose omission by device, Product knowledge deficit, Device leakage, |
||||
SOMATROPIN, SOMATROPIN, METHYLPHENIDATE, METHYLPHENIDATE HYDROCHLORIDE, |
||||
| 592 | 25069209 |
US |
11 | 2 |
Drug dose omission by device, Product communication issue, |
||||
SOMATROGON-GHLA, |
||||
| 593 | 25069260 |
US |
9 | 1 |
Device issue, Device mechanical issue, Device physical property issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 594 | 25069297 |
US |
56 | |
Dyspnoea, Drug dose omission by device, Wrong technique in product usage process, |
||||
ALBUTEROL SULFATE, GUAIFENESIN, DIPHENHYDRAMINE HYDROCHLORIDE, |
||||
| 595 | 25069369 |
US |
67 | 2 |
Knee arthroplasty, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 596 | 25069513 |
US |
78 | |
Dyspnoea, Drug dose omission by device, Wrong technique in product usage process, |
||||
ALBUTEROL SULFATE, HYDROCHLOROTHIAZIDE, ENALAPRIL, |
||||
| 597 | 25069544 |
US |
66 | |
Dyspnoea, Drug dose omission by device, Wrong technique in product usage process, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 598 | 25069699 |
US |
68 | 2 |
Hospitalisation, Dysphonia, Drug intolerance, Off label use, Drug dose omission by device, Device issue, |
||||
AMIKACIN, AMIKACIN, |
||||
| 599 | 25070130 |
US |
61 | |
Dyspnoea, Drug dose omission by device, Wrong technique in product usage process, Device deposit issue, |
||||
ALBUTEROL SULFATE, |
||||
| 600 | 25070155 |
BR |
1 | |
Device adhesion issue, Drug dose omission by device, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, |
||||
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
2025-04-28