Drug:
Reaction: DEVICE ISSUE
20250101 - 20251231
No. 501 - 600
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 501 | 25046197 |
US |
74 | 2 |
Off label use, Device issue, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE, |
||||
| 502 | 25046541 |
US |
71 | |
Needle issue, Product leakage, Device issue, Underdose, |
||||
PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE, |
||||
| 503 | 25047115 |
VN |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 504 | 25047172 |
CA |
||
Device issue, Drug dose omission by device, |
||||
DALTEPARIN SODIUM, |
||||
| 505 | 25047187 |
JP |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 506 | 25047921 |
US |
45 | 2 |
Device issue, Device defective, Product dose omission issue, Off label use, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 507 | 25047988 |
US |
26 | 2 |
Device issue, Product dose omission issue, Off label use, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 508 | 25047991 |
US |
65 | 1 |
Unevaluable event, Device issue, Device issue, |
||||
ADALIMUMAB, |
||||
| 509 | 25047997 |
AU |
84 | 1 |
Femoral neck fracture, Device issue, Heart rate decreased, Hypotension, |
||||
| 510 | 25048049 |
JM |
60 | 2 |
Product dose omission issue, Device issue, |
||||
GOLIMUMAB, |
||||
| 511 | 25048153 |
US |
2 | |
Drug ineffective, Product dose omission issue, Device dispensing error, Incorrect dose administered by device, Device issue, |
||||
ALBUTEROL SULFATE, |
||||
| 512 | 25039040 |
US |
||
Device issue, Needle issue, Device malfunction, Product dose omission issue, Inappropriate schedule of product administration, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 513 | 25039063 |
IT |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 514 | 25039089 |
US |
1 | |
Drug dose omission by device, Device malfunction, Device issue, |
||||
ADALIMUMAB-ADAZ, ADALIMUMAB-ADAZ, |
||||
| 515 | 25039170 |
US |
2 | |
Off label use, Device issue, |
||||
ADALIMUMAB, ADALIMUMAB, |
||||
| 516 | 25039351 |
US |
||
Drug dose omission by device, Device delivery system issue, Device issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 517 | 25039432 |
US |
41 | 2 |
Influenza, Accidental exposure to product, Wrong technique in device usage process, Product dose omission issue, Device issue, |
||||
FREMANEZUMAB-VFRM, |
||||
| 518 | 25040584 |
US |
40 | 1 |
Product dose omission issue, Product leakage, Device issue, |
||||
GUSELKUMAB, GUSELKUMAB, |
||||
| 519 | 25040634 |
US |
||
Product use complaint, Product packaging quantity issue, Device issue, Wrong technique in product usage process, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 520 | 25040908 |
US |
5 | 2 |
Off label use, Device issue, Accidental exposure to product, Product dose omission issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 521 | 25041032 |
US |
||
Drug dose omission by device, Device issue, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 522 | 25041081 |
AE |
||
Device defective, Device issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 523 | 25041470 |
US |
55 | 2 |
Sleep deficit, Nausea, Fatigue, Device occlusion, Device alarm issue, Device issue, |
||||
TREPROSTINIL, TREPROSTINIL, ALPRAZOLAM, CETIRIZINE HYDROCHLORIDE, VITAMIN C, OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN, AMOXICILLIN, SODIUM CHLORIDE, SODIUM CHLORIDE INJECTION, SODIUM CHLORIDE TABLET, NORMAL SALT TABLETS, LEVOTHYROXINE SODIUM, GABAPENTIN, IRON, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CONTINUOUS SPRAY, ANTI-PRURITIC, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, HYDROCORTISONE LOTION KIT, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE CREAM 1%, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, METRONIDAZOLE, TADALAFIL, LORATADINE, LORATADINE TABLET, OXYGEN, 0XYGEN, CALCIUM, OMEPRAZOLE MAGNESIUM, ESCITALOPRAM, |
||||
| 524 | 25041504 |
US |
1 | |
Psoriasis, Device issue, Drug dose omission by device, |
||||
SECUKINUMAB, |
||||
| 525 | 25041514 |
CA |
45 | 2 |
Device issue, Product dose omission issue, |
||||
GOLIMUMAB, |
||||
| 526 | 25042166 |
EG |
12 | 2 |
Expired device used, Device issue, |
||||
SOMATROPIN, |
||||
| 527 | 25042206 |
FR |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 528 | 25042220 |
US |
2 | |
Injection site haemorrhage, Device issue, |
||||
ADALIMUMAB, ADALIMUMAB, |
||||
| 529 | 25042348 |
CA |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 530 | 25042637 |
ZA |
1 | |
Cystoid macular oedema, Device issue, |
||||
DEXAMETHASONE, |
||||
| 531 | 25043124 |
US |
2 | |
Device issue, Incorrect dose administered by product, |
||||
ESKETAMINE HYDROCHLORIDE, |
||||
| 532 | 25034236 |
US |
82 | 2 |
Device issue, Product dose omission issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 533 | 25034312 |
US |
2 | |
Off label use, Incorrect dose administered, Device issue, No adverse event, |
||||
OMALIZUMAB, OMALIZUMAB, |
||||
| 534 | 25034393 |
US |
2 | |
Device issue, Product dose omission issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 535 | 25034478 |
US |
67 | 1 |
Device issue, Device leakage, Catheter site haemorrhage, Cough, Dyspnoea, Scrotal swelling, |
||||
TREPROSTINIL, TREPROSTINIL, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, AMOXICILLIN, LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE, FAMOTIDINE, SODIUM CHLORIDE, SODIUM CHLORIDE INJECTION, SODIUM CHLORIDE TABLET, NORMAL SALT TABLETS, CLINDAMYCIN HYDROCHLORIDE, BUMETANIDE, TADALAFIL, SIMVASTATIN, MACITENTAN, ACETAZOLAMIDE SODIUM, ACETAZOLAMIDE, SPIRONOLACTONE, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, ONDANSETRON HYDROCHLORIDE, |
||||
| 536 | 25034608 |
US |
1 | |
Injection site haemorrhage, Device issue, |
||||
ADALIMUMAB, |
||||
| 537 | 25034662 |
US |
1 | |
Hypoacusis, Device issue, |
||||
TIOTROPIUM BROMIDE AND OLODATEROL, |
||||
| 538 | 25034782 |
US |
1 | |
Hospitalisation, Device connection issue, Device issue, Drug dose omission by device, Product dose omission issue, Therapy interrupted, Intentional dose omission, |
||||
AMIKACIN, |
||||
| 539 | 25034832 |
US |
39 | 2 |
Device issue, Product dose omission issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 540 | 25035093 |
US |
2 | |
Device issue, Therapeutic response delayed, |
||||
ESKETAMINE HYDROCHLORIDE, |
||||
| 541 | 25035127 |
US |
||
Myasthenia gravis crisis, Meningitis noninfective, Back pain, Fatigue, Pyrexia, Headache, Infusion related reaction, Nausea, Vomiting, Device issue, Incorrect drug administration rate, |
||||
RAVULIZUMAB, |
||||
| 542 | 25035497 |
FR |
2 | |
Device issue, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
| 543 | 25035620 |
US |
||
Device issue, Product dose omission issue, |
||||
RISPERIDONE, RISPERIDONE, RISPERIDONE, RISPERIDONE, |
||||
| 544 | 25035663 |
US |
48 | 2 |
Circumstance or information capable of leading to device use error, Device issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 545 | 25035810 |
US |
41 | 1 |
Device issue, Product dose omission issue, |
||||
GUSELKUMAB, GUSELKUMAB, |
||||
| 546 | 25036544 |
AU |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 547 | 25036600 |
US |
||
Device issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 548 | 25036906 |
US |
25 | 1 |
Product dose omission issue, Device issue, Off label use, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 549 | 25037017 |
CO |
6 | 1 |
Device issue, |
||||
SOMATROPIN, |
||||
| 550 | 25037068 |
GB |
||
Device issue, |
||||
MEDROXYPROGESTERONE ACETATE, |
||||
| 551 | 25037089 |
CO |
16 | 1 |
Off label use, Device mechanical issue, Device malfunction, Device issue, Device defective, |
||||
SOMATROPIN, |
||||
| 552 | 25037196 |
US |
2 | |
Off label use, Device issue, Device malfunction, Device delivery system issue, |
||||
FLUTICASONE PROPIONATE AND SALMETEROL, |
||||
| 553 | 25037201 |
JP |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 554 | 25037289 |
HK |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 555 | 25037454 |
US |
25 | 1 |
Needle issue, Product dose omission issue, Device issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 556 | 25037725 |
US |
38 | 2 |
Device issue, Accidental exposure to product, Product dose omission issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 557 | 25037873 |
TR |
39 | 2 |
Pain, Device issue, Drug dose omission by device, |
||||
ETANERCEPT, |
||||
| 558 | 25037940 |
FR |
68 | 2 |
Product dose omission issue, Device issue, |
||||
GUSELKUMAB, |
||||
| 559 | 25038169 |
US |
2 | |
Injection site haemorrhage, Device issue, |
||||
ADALIMUMAB, |
||||
| 560 | 25038486 |
AU |
1 | |
Product dose omission issue, Device issue, Wrong technique in device usage process, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 561 | 25038499 |
BR |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 562 | 25038666 |
JP |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 563 | 25038681 |
US |
||
Device issue, Incorrect dose administered by device, |
||||
ESKETAMINE HYDROCHLORIDE, |
||||
| 564 | 25029138 |
US |
69 | 2 |
Off label use, Post procedural complication, Cataract, Device issue, Product quality issue, |
||||
TIOTROPIUM BROMIDE INHALATION SPRAY, |
||||
| 565 | 25029338 |
US |
22 | 2 |
Device issue, Product preparation issue, No adverse event, Device issue, |
||||
| 566 | 25029410 |
US |
1 | |
Hospitalisation, Device issue, |
||||
CARBIDOPA AND LEVODOPA, CARBIDOPA AND LEVODOPA, CARBIDOPA AND LEVODOPA, ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITSLOPRAM, LEVODOPA, ISTRADEFYLLINE, PRAMIPEXOLE, |
||||
| 567 | 25029413 |
AR |
85 | 2 |
Peripheral swelling, Mobility decreased, Device issue, Product dose omission issue, |
||||
GOLIMUMAB, |
||||
| 568 | 25029475 |
US |
66 | 1 |
Injection site pain, Device issue, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, |
||||
| 569 | 25030051 |
EG |
2 | |
Expired device used, Incorrect dose administered by device, Device issue, |
||||
SOMATROPIN, |
||||
| 570 | 25030140 |
US |
1 | |
Product dose omission issue, Device issue, |
||||
RISPERIDONE, RISPERIDONE, RISPERIDONE, RISPERIDONE, |
||||
| 571 | 25030234 |
US |
63 | 1 |
Product dose omission issue, Device defective, Product complaint, Device issue, No adverse event, |
||||
OMALIZUMAB, OMALIZUMAB, LOSARTAN, METOPROLOL TARTRATE, METOPROLOL, FENOFIBRATE, |
||||
| 572 | 25030496 |
US |
51 | 2 |
Surgery, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 573 | 25030509 |
US |
6 | 1 |
Off label use, Product dose omission issue, Device issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 574 | 25030618 |
DE |
2 | |
Asthma, Device issue, Incorrect dose administered by device, Incorrect dose administered by device, Device dispensing error, |
||||
OMALIZUMAB, |
||||
| 575 | 25030641 |
US |
22 | 2 |
Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 576 | 25030731 |
DE |
||
Device issue, |
||||
GUSELKUMAB, GUSELKUMAB, |
||||
| 577 | 25030989 |
US |
53 | 2 |
Syringe issue, Device issue, Product dose omission issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 578 | 25031250 |
US |
1 | |
Device issue, Product dose omission issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 579 | 25031307 |
US |
||
Device issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 580 | 25031451 |
US |
74 | 1 |
Device issue, Fall, Neck pain, Axillary pain, Arthralgia, Breast pain, |
||||
IBRUTINIB, IBRUTINIB, IBRUTINIB, IBRUTINIB, GABAPENTIN, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, METHOCARBAMOL, METHOCARBAMOL TABLETS, DAPAGLIFLOZIN, METHYLPREDNISOLONE, |
||||
| 581 | 25031860 |
BR |
||
Device issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 582 | 25031955 |
VN |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 583 | 25032184 |
US |
32 | 1 |
Device issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 584 | 25032233 |
AE |
||
Device leakage, Device issue, Drug dose omission by device, |
||||
SOMATROGON-GHLA, |
||||
| 585 | 25032235 |
CL |
||
Device leakage, Device issue, Poor quality device used, |
||||
SOMATROPIN, CALCIUM, FISH OIL, |
||||
| 586 | 25032341 |
US |
48 | 2 |
Device expulsion, Device issue, |
||||
LEVONORGESTREL, |
||||
| 587 | 25032342 |
GB |
||
Device issue, |
||||
PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE, |
||||
| 588 | 25032427 |
KR |
||
Device issue, |
||||
GUSELKUMAB, |
||||
| 589 | 25032475 |
US |
||
Liquid product physical issue, Wrong technique in product usage process, Device issue, Device delivery system issue, |
||||
ROZANOLIXIZUMAB, |
||||
| 590 | 25032764 |
US |
||
Injury associated with device, Needle issue, Device issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 591 | 25033068 |
AR |
4 | 1 |
Needle issue, Device issue, Device use error, |
||||
SOMATROPIN, |
||||
| 592 | 25033783 |
US |
2 | |
Knee arthroplasty, Device issue, |
||||
ADALIMUMAB, |
||||
| 593 | 25033803 |
US |
52 | 1 |
Device issue, Product leakage, Product dose omission issue, |
||||
USTEKINUMAB, USTEKINUMAB, USTEKINUMAB, ATORVASTATIN CALCIUM, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS, |
||||
| 594 | 25033910 |
US |
56 | 2 |
Unintentional medical device removal, Device issue, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, |
||||
| 595 | 25028526 |
US |
2 | |
Drug ineffective, Device dispensing error, Device issue, |
||||
SECUKINUMAB, SECUKINUMAB, SECUKINUMAB, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, DOXYCYCLINE, DOXYCYCLINE HYCLATE, METHYLPHENIDATE, METHYLPHENIDATE HYDROCHLORIDE, SPIRONOLACTONE, |
||||
| 596 | 25028647 |
US |
68 | 2 |
Gait inability, Musculoskeletal stiffness, Device issue, Pain, Muscular weakness, Injection site erythema, Injection site pain, Injection site papule, Peripheral swelling, Arthritis, |
||||
ADALIMUMAB, ADALIMUMAB, |
||||
| 597 | 25028820 |
NL |
81 | 1 |
Eye operation, Off label use, Faecal volume decreased, Dyschezia, Off label use, Constipation, Device issue, |
||||
RIVASTIGMINE, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, PANTOPRAZOLE, SIMVASTATIN, HYDROXOCOBALAMIN, |
||||
| 598 | 25028858 |
FR |
1 | |
Product dose omission issue, Device issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 599 | 25025691 |
US |
74 | 1 |
Injection site vesicles, Injection site pain, Device issue, Injection site mass, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 600 | 25025707 |
US |
1 | |
Blister, Wrong technique in product usage process, Device issue, |
||||
LIRAGLUTIDE, |
||||
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