Drug:
Reaction: DEVICE ISSUE
20250101 - 20251231
No. 301 - 400
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 301 | 25081342 |
US |
2 | |
Surgery, Wrong technique in device usage process, Product dose omission issue, Device issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 302 | 25080402 |
US |
61 | 1 |
Eye irritation, Tear discolouration, Device physical property issue, Device issue, Device occlusion, Device occlusion, |
||||
TREPROSTINIL, TREPROSTINIL, SODIUM CHLORIDE, SODIUM CHLORIDE INJECTION, SODIUM CHLORIDE TABLET, NORMAL SALT TABLETS, MACITENTAN, KETAMINE HYDROCHLORIDE, TADALAFIL, CLONIDINE, KETOPROFEN, SPIRONOLACTONE, LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE ANHYDROUS, HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE, FUROSEMIDE, AMITRIPTYLINE HYDROCHLORIDE, GABAPENTIN, |
||||
| 303 | 25081095 |
US |
63 | 2 |
Pharyngeal swelling, Urinary tract infection, Device issue, Drug hypersensitivity, Allergy to plants, |
||||
ADALIMUMAB, ADALIMUMAB, VALACYCLOVIR, VALACYCLOVIR HYDROCHLORIDE, ROSUVASTATIN, CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE, |
||||
| 304 | 25076952 |
US |
12 | 2 |
Needle issue, Mood altered, Screaming, Product dose omission issue, Pain, Nerve compression, Device issue, Inappropriate schedule of product administration, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 305 | 25076960 |
US |
75 | 2 |
Spinal operation, Back pain, Post-traumatic stress disorder, Device issue, |
||||
RISANKIZUMAB-RZAA, |
||||
| 306 | 25076968 |
US |
48 | 1 |
Product temperature excursion issue, Psoriasis, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 307 | 25076978 |
US |
2 | |
Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 308 | 25077049 |
EC |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 309 | 25077064 |
US |
67 | 2 |
Sepsis, Device issue, Needle issue, |
||||
SECUKINUMAB, IRBESARTAN, LEVOTHYROXINE, FUROSEMIDE, SERTRALINE, HYDROXYCHLOROQUINE, LEFLUNOMIDE, METAXALONE, PROGESTERONE, DULOXETINE HYDROCHLORIDE, DULOXETINE, PREGABALIN, OXYCODONE, |
||||
| 310 | 25078093 |
EG |
2 | |
Expired device used, Drug administered in wrong device, Incorrect dose administered by device, Device issue, |
||||
SOMATROPIN, |
||||
| 311 | 25078143 |
US |
50 | 1 |
Injection site haemorrhage, Device issue, Injection site erythema, Injection site papule, |
||||
ADALIMUMAB, DULAGLUTIDE, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, EMPAGLIFLOZIN, |
||||
| 312 | 25078205 |
US |
1 | |
Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 313 | 25078580 |
US |
2 | |
Device issue, Accidental exposure to product, Drug dose omission by device, Device leakage, |
||||
SECUKINUMAB, CLINDAMYCIN PHOSPHATE, CLINDAMYCIN, |
||||
| 314 | 25079138 |
SA |
||
Device issue, Product dose omission issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 315 | 25079148 |
AU |
67 | 1 |
Dementia, Drug dose omission by device, Device difficult to use, Device issue, Device leakage, |
||||
FREMANEZUMAB-VFRM, FREMANEZUMAB-VFRM, |
||||
| 316 | 25079380 |
US |
18 | 2 |
Contusion, Device malfunction, Accidental exposure to product, Device issue, Needle issue, Burning sensation, |
||||
FREMANEZUMAB-VFRM, |
||||
| 317 | 25079734 |
US |
71 | 2 |
Device issue, Product dose omission issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 318 | 25079752 |
US |
||
Device issue, Product dose omission issue, |
||||
RISPERIDONE, RISPERIDONE, RISPERIDONE, RISPERIDONE, |
||||
| 319 | 25079785 |
US |
67 | 1 |
Injection site haemorrhage, Device issue, |
||||
ADALIMUMAB, |
||||
| 320 | 25079922 |
JP |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 321 | 25080272 |
US |
2 | |
Hip surgery, Device issue, Device issue, |
||||
CARBIDOPA AND LEVODOPA, CARBIDOPA AND LEVODOPA, FLUTICASONE PROPIONATE, CLONAZEPAM, LEVOTHYROXINE SODIUM, ERGOCALCIFEROL, MAGNESIUM, |
||||
| 322 | 25071640 |
US |
1 | |
Intestinal obstruction, Peripheral swelling, Arthralgia, Infection, Weight decreased, Aspiration, Pneumonia, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, PREDNISONE, |
||||
| 323 | 25071653 |
DE |
||
Device issue, |
||||
DARUNAVIR, DARUNAVIR, |
||||
| 324 | 25071656 |
ES |
1 | |
Ulcer, Pyrexia, Depressed mood, Incorrect route of product administration, Device issue, Freezing phenomenon, Drug ineffective, |
||||
| 325 | 25072083 |
US |
66 | 1 |
Product dose omission issue, Dyspnoea, Cough, Device calibration failure, Device issue, |
||||
TIOTROPIUM BROMIDE AND OLODATEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 326 | 25072212 |
US |
2 | |
Respiratory rate increased, Influenza, Device issue, |
||||
ALBUTEROL SULFATE, |
||||
| 327 | 25072213 |
US |
2 | |
Circumstance or information capable of leading to device use error, Device issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 328 | 25072329 |
TR |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 329 | 25072438 |
US |
||
Device issue, |
||||
GOLIMUMAB, GOLIMUMAB, |
||||
| 330 | 25072447 |
US |
||
Incorrect dose administered by device, Product quality issue, Device issue, Product leakage, |
||||
LANREOTIDE ACETATE, |
||||
| 331 | 25072453 |
US |
||
Drug dose omission by device, Syringe issue, Needle issue, Device issue, |
||||
LANREOTIDE ACETATE, |
||||
| 332 | 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, |
||||
| 333 | 25072915 |
DE |
72 | 1 |
Lumbar vertebral fracture, Fall, Device issue, Wrong route, |
||||
| 334 | 25072975 |
US |
75 | |
Product storage error, Device issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 335 | 25073211 |
US |
1 | |
Wrong technique in product usage process, Device issue, |
||||
ADALIMUMAB-ADAZ, |
||||
| 336 | 25073449 |
US |
50 | 2 |
Injection site discharge, Hepatic enzyme increased, Musculoskeletal stiffness, Pain in extremity, Pain, Device issue, |
||||
ADALIMUMAB, ARIPIPRAZOLE, HYDROXYZINE, |
||||
| 337 | 25074415 |
US |
||
Injection site haemorrhage, Product dose omission issue, Device issue, Syringe issue, |
||||
IBANDRONATE SODIUM, |
||||
| 338 | 25074530 |
US |
37 | 2 |
Device issue, |
||||
NITRIC OXIDE, |
||||
| 339 | 25074536 |
US |
||
Device issue, |
||||
NITRIC OXIDE, |
||||
| 340 | 25074537 |
US |
||
Device issue, |
||||
NITRIC OXIDE, |
||||
| 341 | 25074988 |
US |
||
Product dose omission issue, Device use issue, Device issue, Incorrect dose administered, |
||||
PEGCETACOPLAN, |
||||
| 342 | 25076166 |
US |
24 | 2 |
General anaesthesia, Implant site scar, Device issue, Device issue, Device deployment issue, Complication associated with device, Complication of device removal, Product quality issue, Overdose, |
||||
ETONOGESTREL, ETONOGESTREL, ETONOGESTREL, |
||||
| 343 | 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, |
||||
| 344 | 25076321 |
US |
61 | 2 |
Internal haemorrhage, Device issue, Crohn^s disease, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 345 | 25076521 |
AR |
10 | 2 |
Device issue, |
||||
SOMATROPIN, |
||||
| 346 | 25076770 |
US |
63 | 2 |
Injection site bruising, Device issue, |
||||
RISANKIZUMAB-RZAA, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, IRON, VITAMIN C, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, |
||||
| 347 | 25076780 |
US |
72 | 1 |
Cholelithiasis, Necrosis, Pain, Device issue, Abdominal pain, Hypertension, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 348 | 25076801 |
US |
1 | |
Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 349 | 25076802 |
US |
52 | 2 |
Injection site haemorrhage, Device issue, |
||||
ADALIMUMAB, |
||||
| 350 | 25076804 |
US |
78 | 1 |
Hypoacusis, Device issue, |
||||
RISANKIZUMAB-RZAA, |
||||
| 351 | 25066107 |
US |
||
Night sweats, Device issue, |
||||
PEGFILGRASTIM, |
||||
| 352 | 25066210 |
US |
||
Injection site papule, Device issue, |
||||
ADALIMUMAB, |
||||
| 353 | 25066242 |
US |
||
Injection site bruising, Device issue, Product dose omission issue, |
||||
TEZEPELUMAB-EKKO, |
||||
| 354 | 25066488 |
CL |
||
Circumstance or information capable of leading to device use error, Device issue, Device leakage, |
||||
ADALIMUMAB-ADAZ, |
||||
| 355 | 25066499 |
US |
42 | 2 |
Product storage error, Injection site haemorrhage, Device issue, Injection site discharge, |
||||
ADALIMUMAB, |
||||
| 356 | 25066503 |
CH |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 357 | 25066521 |
US |
||
Device issue, Device malfunction, Product use issue, Drug dose omission by device, |
||||
INFLIXIMAB-DYYB, |
||||
| 358 | 25066723 |
US |
2 | |
Accidental exposure to product, Product dose omission issue, Device issue, |
||||
SECUKINUMAB, |
||||
| 359 | 25066817 |
US |
||
Device issue, Device leakage, |
||||
DIAZEPAM, DIAZEPAM ORAL, DIAZEPAM ORAL SOLUTION (CONCENTRATE), |
||||
| 360 | 25066984 |
US |
70 | 1 |
Device issue, |
||||
PEGFILGRASTIM, |
||||
| 361 | 25067044 |
US |
||
Product dose omission issue, Drug ineffective, Device issue, Product container seal issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 362 | 25067120 |
CH |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 363 | 25067498 |
US |
2 | |
Device issue, Device leakage, Accidental exposure to product, |
||||
SECUKINUMAB, ROMOSOZUMAB-AQQG, |
||||
| 364 | 25067543 |
US |
1 | |
Injection site haemorrhage, Device issue, |
||||
ADALIMUMAB, ADALIMUMAB-FKJP, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, |
||||
| 365 | 25068112 |
US |
29 | 1 |
Device issue, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
| 366 | 25068258 |
CH |
81 | 1 |
Hypertensive crisis, Hypertension, Headache, Freezing phenomenon, Device issue, Mobility decreased, |
||||
TRAZODONE HYDROCHLORIDE, |
||||
| 367 | 25069004 |
US |
66 | 2 |
Back disorder, Blood glucose decreased, Device issue, Intentional product misuse, |
||||
INSULIN GLARGINE, |
||||
| 368 | 25069200 |
IT |
50 | 1 |
Drug dose omission by device, Device occlusion, Device issue, |
||||
SOMATROPIN, |
||||
| 369 | 25069205 |
US |
13 | 2 |
Device use error, Device issue, |
||||
SOMATROPIN, |
||||
| 370 | 25069260 |
US |
9 | 1 |
Device issue, Device mechanical issue, Device physical property issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 371 | 25069699 |
US |
68 | 2 |
Hospitalisation, Dysphonia, Drug intolerance, Off label use, Drug dose omission by device, Device issue, |
||||
AMIKACIN, AMIKACIN, |
||||
| 372 | 25069797 |
US |
||
Device issue, Incorrect dose administered by device, |
||||
ESKETAMINE HYDROCHLORIDE, |
||||
| 373 | 25069817 |
AR |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 374 | 25070283 |
US |
2 | |
Device issue, Device malfunction, Wrong technique in device usage process, |
||||
FLUTICASONE PROPIONATE AND SALMETEROL, |
||||
| 375 | 25070310 |
US |
2 | |
Product packaging issue, Device issue, |
||||
SEMAGLUTIDE, |
||||
| 376 | 25070823 |
US |
88 | 2 |
Blood glucose increased, Device issue, Product storage error, |
||||
INSULIN GLARGINE, |
||||
| 377 | 25070882 |
US |
82 | 1 |
Blood glucose increased, Device issue, Intentional product misuse, |
||||
INSULIN GLARGINE, INSULIN GLARGINE, |
||||
| 378 | 25071054 |
US |
86 | 1 |
Contusion, Fall, Urinary tract infection, Device issue, |
||||
CYANOCOBALAMIN, DONEPEZIL HYDROCHLORIDE, MONTELUKAST, BENZONATATE, ERGOCALCIFEROL, |
||||
| 379 | 25071058 |
US |
1 | |
Hernia, Device issue, |
||||
RISANKIZUMAB-RZAA, |
||||
| 380 | 25071074 |
US |
39 | 2 |
Abnormal uterine bleeding, Device issue, Heavy menstrual bleeding, |
||||
LEVONORGESTREL, |
||||
| 381 | 25071248 |
US |
37 | 2 |
Product dose omission issue, Device issue, Product packaging issue, Nasopharyngitis, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 382 | 25061296 |
AU |
1 | |
Product dose omission issue, Device issue, |
||||
GOLIMUMAB, |
||||
| 383 | 25061423 |
US |
60 | 1 |
Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 384 | 25061671 |
US |
69 | 2 |
Surgery, Device issue, |
||||
RISANKIZUMAB-RZAA, |
||||
| 385 | 25061808 |
US |
64 | 2 |
Device issue, Product dose omission issue, |
||||
ABATACEPT, |
||||
| 386 | 25062379 |
CA |
64 | 2 |
Myocardial infarction, Device issue, Post procedural stroke, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 387 | 25062444 |
US |
||
Pneumonia, Wheezing, Product taste abnormal, Device issue, Device use issue, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 388 | 25062794 |
US |
||
Device issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 389 | 25062847 |
US |
1 | |
Device issue, |
||||
CARBIDOPA AND LEVODOPA, CARBIDOPA AND LEVODOPA, |
||||
| 390 | 25063334 |
EG |
||
Device issue, Device issue, Product dose omission issue, |
||||
GOLIMUMAB, GOLIMUMAB, |
||||
| 391 | 25063591 |
US |
53 | 2 |
Therapeutic product ineffective, Product administered at inappropriate site, Product dose omission issue, Product storage error, Product adhesion issue, Product residue present, Device issue, |
||||
| 392 | 25063596 |
CA |
69 | 2 |
Device issue, Pain, Contusion, |
||||
GOLIMUMAB, |
||||
| 393 | 25063625 |
US |
56 | 2 |
Product dose omission issue, Device issue, |
||||
GUSELKUMAB, |
||||
| 394 | 25063832 |
US |
||
Device issue, |
||||
SOMATROPIN, |
||||
| 395 | 25063833 |
CA |
||
Device issue, Device difficult to use, |
||||
DALTEPARIN SODIUM, |
||||
| 396 | 25063969 |
US |
2 | |
Intermenstrual bleeding, Device issue, |
||||
LEVONORGESTREL, |
||||
| 397 | 25064079 |
AU |
||
Device issue, Product dose omission issue, |
||||
GOLIMUMAB, |
||||
| 398 | 25064159 |
US |
14 | 1 |
Device issue, Device mechanical issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 399 | 25064272 |
US |
73 | 2 |
Deep vein thrombosis, Cellulitis, Staphylococcal infection, Immunodeficiency, Pain, Nausea, Gait inability, Cerebrovascular accident, Thrombosis, Diarrhoea, Balance disorder, Dizziness, White blood cell count decreased, Immune thrombocytopenia, Device issue, |
||||
RISANKIZUMAB-RZAA, FOSTAMATINIB, VENLAFAXINE HYDROCHLORIDE, AMLODIPINE, HYDROCHLOROTHIAZIDE, CARVEDILOL, LOSARTAN, LEVOTHYROXINE, |
||||
| 400 | 25064385 |
US |
17 | 1 |
Device issue, Drug dose omission by device, |
||||
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
2025-04-28