Drug:
Reaction: DEVICE MALFUNCTION
20260101 - 20261231
No. 201 - 300
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 201 | 26518574 |
US |
2 | |
Device defective, Device malfunction, |
||||
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE, |
||||
| 202 | 26518585 |
US |
||
Device mechanical issue, Device malfunction, |
||||
SUMATRIPTAN SUCCINATE, |
||||
| 203 | 26518587 |
US |
2 | |
Device malfunction, |
||||
SUMATRIPTAN SUCCINATE, |
||||
| 204 | 26518589 |
US |
2 | |
Device malfunction, |
||||
SUMATRIPTAN SUCCINATE, |
||||
| 205 | 26518969 |
US |
34 | 2 |
Colitis ulcerative, Device malfunction, Incorrect dose administered, |
||||
VEDOLIZUMAB, VEDOLIZUMAB, |
||||
| 206 | 26519854 |
US |
||
Device malfunction, Device delivery system issue, Off label use, |
||||
ALBUTEROL SULFATE, |
||||
| 207 | 26520683 |
US |
63 | 1 |
Product use in unapproved indication, Device malfunction, Device mechanical issue, |
||||
FLUTICASONE PROPIONATE AND SALMETEROL, |
||||
| 208 | 26520729 |
US |
||
Device malfunction, Visual impairment, Product dose omission issue, Expired product administered, Product packaging issue, Device mechanical issue, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 209 | 26512266 |
US |
56 | |
Incorrect dose administered, Device malfunction, Inappropriate schedule of product administration, |
||||
GUSELKUMAB, GUSELKUMAB, |
||||
| 210 | 26512543 |
US |
1 | |
Device malfunction, Device malfunction, No adverse event, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 211 | 26512823 |
US |
1 | |
Dyspnoea, Device issue, Device malfunction, |
||||
TIOTROPIUM BROMIDE AND OLODATEROL, |
||||
| 212 | 26513083 |
US |
||
Device malfunction, |
||||
NITRIC OXIDE, |
||||
| 213 | 26513085 |
US |
||
Device malfunction, |
||||
NITRIC OXIDE, |
||||
| 214 | 26513086 |
US |
||
Device malfunction, |
||||
NITRIC OXIDE, |
||||
| 215 | 26513117 |
US |
2 | |
Feeling abnormal, Arthralgia, Needle issue, Device malfunction, |
||||
SECUKINUMAB, |
||||
| 216 | 26513670 |
US |
2 | |
Dyspnoea, Intentional product misuse, Device malfunction, Wrong technique in product usage process, Drug dose omission by device, Device use issue, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 217 | 26514298 |
US |
||
Injection site haemorrhage, Incorrect dose administered, Device malfunction, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 218 | 26514305 |
US |
1 | |
Wrong technique in product usage process, Drug dose omission by device, Device malfunction, Product quality issue, |
||||
ALBUTEROL SULFATE AND BUDESONIDE, |
||||
| 219 | 26514403 |
US |
41 | 1 |
Off label use, Device malfunction, Device delivery system issue, Product quality issue, |
||||
PRAMOXINE HYDROCHLORIDE HYDROCORTISONE ACETATE, |
||||
| 220 | 26515156 |
US |
||
Device malfunction, Incorrect dose administered, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 221 | 26515767 |
US |
2 | |
Device malfunction, |
||||
ABATACEPT, |
||||
| 222 | 26515892 |
US |
43 | 2 |
Haematochezia, Hidradenitis, Pain, Erythema, Pruritus, Condition aggravated, Crying, Device leakage, Drug dose omission by device, Device malfunction, |
||||
SECUKINUMAB, SULFAMETHOXAZOLE AND TRIMETHOPRIM, |
||||
| 223 | 26515893 |
US |
||
Device malfunction, Incorrect dose administered, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 224 | 26515957 |
US |
||
Injection site reaction, Injection site pain, Device malfunction, Abnormal loss of weight, Drug dose omission by device, |
||||
FREMANEZUMAB-VFRM, |
||||
| 225 | 26516455 |
CO |
16 | 1 |
Drug dose omission by device, Off label use, Device power source issue, Device information output issue, Device issue, Device mechanical issue, Device malfunction, Device breakage, Device deployment issue, Device physical property issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 226 | 26516476 |
UY |
13 | 1 |
Device deposit issue, Device delivery system issue, Device malfunction, Device physical property issue, Device information output issue, Device mechanical issue, |
||||
SOMATROPIN, SOMATROPIN, SOMATROPIN, |
||||
| 227 | 26507756 |
US |
||
Device malfunction, |
||||
GUSELKUMAB, |
||||
| 228 | 26507893 |
|||
Pneumonia, Infection, Wrong technique in device usage process, Device malfunction, |
||||
BIMEKIZUMAB, |
||||
| 229 | 26507938 |
US |
||
Device malfunction, |
||||
PEGFILGRASTIM, |
||||
| 230 | 26507953 |
US |
2 | |
Malaise, Device malfunction, Inappropriate schedule of product administration, Device use issue, Device malfunction, Malaise, Inappropriate schedule of product administration, Device use issue, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 231 | 26508139 |
US |
2 | |
Injection site haemorrhage, Device malfunction, Accidental exposure to product, |
||||
BENRALIZUMAB, BENRALIZUMAB, |
||||
| 232 | 26508377 |
US |
||
Device malfunction, Product dose omission issue, Device malfunction, Product dose omission issue, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 233 | 26508440 |
US |
||
Injection site indentation, Device malfunction, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 234 | 26508771 |
US |
||
Device malfunction, Device malfunction, No adverse event, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 235 | 26510468 |
US |
||
Device malfunction, Off label use, Intentional overdose, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 236 | 26510718 |
US |
1 | |
Bradykinesia, Device malfunction, Memory impairment, Accidental exposure to product, Wrong technique in product usage process, Product administration error, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 237 | 26511022 |
US |
||
Drug dose omission by device, Device malfunction, Product knowledge deficit, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 238 | 26511442 |
US |
1 | |
Device malfunction, Device delivery system issue, |
||||
INTERFERON BETA-1A, INTERFERON BETA-1A, INTERFERON BETA-1A, INTERFERON BETA-1A, |
||||
| 239 | 26511663 |
US |
2 | |
Device malfunction, Drug dose omission by device, Device leakage, Accidental exposure to product, |
||||
SECUKINUMAB, |
||||
| 240 | 26512018 |
US |
||
Injection site haemorrhage, Device malfunction, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 241 | 26512037 |
US |
||
Off label use, Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 242 | 26503112 |
45 | ||
Psoriatic arthropathy, Device malfunction, Product dose omission issue, Insurance issue, |
||||
BIMEKIZUMAB, BIMEKIZUMAB, |
||||
| 243 | 26503167 |
US |
2 | |
Wrong technique in device usage process, Product storage error, Device issue, Device malfunction, Drug dose omission by device, |
||||
OFATUMUMAB, |
||||
| 244 | 26503440 |
US |
1 | |
Dysphonia, Vision blurred, Dyspnoea, Oxygen therapy, Therapy change, Product dose omission issue, Device malfunction, Device failure, Positive airway pressure therapy, Taste disorder, Dysgeusia, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 245 | 26503606 |
US |
||
Device malfunction, Incorrect dose administered, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 246 | 26503686 |
US |
2 | |
Device malfunction, Device delivery system issue, Device leakage, |
||||
| 247 | 26504170 |
US |
||
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 248 | 26504537 |
US |
2 | |
Injury, Accidental exposure to product, Product dose omission issue, Incorrect dose administered, Wrong technique in device usage process, Device leakage, Device malfunction, |
||||
BENRALIZUMAB, BENRALIZUMAB, |
||||
| 249 | 26504679 |
61 | ||
Hidradenitis, Condition aggravated, Peripheral swelling, Device malfunction, Product leakage, Incorrect dose administered, |
||||
BIMEKIZUMAB, BIMEKIZUMAB, ADALIMUMAB, |
||||
| 250 | 26504994 |
US |
59 | 2 |
Accidental exposure to product, Device malfunction, |
||||
ADALIMUMAB-ADBM, |
||||
| 251 | 26505727 |
US |
||
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 252 | 26506006 |
US |
2 | |
Wrong technique in device usage process, Device malfunction, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE, |
||||
| 253 | 26506724 |
US |
17 | 2 |
Injection site erythema, Injection site irritation, Device malfunction, |
||||
FREMANEZUMAB-VFRM, |
||||
| 254 | 26506871 |
US |
12 | 1 |
Therapy cessation, Wrong technique in device usage process, Incorrect dose administered, Device leakage, Device malfunction, |
||||
SOMATROPIN, |
||||
| 255 | 26507045 |
US |
46 | 2 |
Device deployment issue, Device malfunction, Accidental exposure to product, Device leakage, |
||||
OFATUMUMAB, |
||||
| 256 | 26507075 |
EU |
||
Device malfunction, |
||||
EPOETIN ALFA-EPBX, |
||||
| 257 | 26507460 |
US |
||
Device malfunction, Incorrect dose administered, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 258 | 26507478 |
44 | ||
Device defective, Device malfunction, Accidental exposure to product, Product dose omission issue, |
||||
BIMEKIZUMAB, |
||||
| 259 | 26507534 |
US |
||
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 260 | 26507539 |
42 | ||
Device malfunction, Product dose omission issue, |
||||
BIMEKIZUMAB, |
||||
| 261 | 26497981 |
US |
84 | 2 |
Device malfunction, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 262 | 26498318 |
US |
67 | 1 |
Device malfunction, Asthma, Dyspnoea, Product cleaning inadequate, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 263 | 26499128 |
US |
73 | |
Dyspnoea, Product dose omission issue, Off label use, Product preparation error, Device malfunction, |
||||
ALBUTEROL SULFATE, |
||||
| 264 | 26499479 |
55 | ||
Accidental exposure to product, Device issue, Device malfunction, Product quality issue, Product dose omission issue, |
||||
BIMEKIZUMAB, |
||||
| 265 | 26500083 |
2 | ||
Rash, Device malfunction, |
||||
| 266 | 26500118 |
US |
||
Device malfunction, Incorrect dose administered by device, |
||||
ESKETAMINE HYDROCHLORIDE, |
||||
| 267 | 26500515 |
US |
||
Product dose omission issue, Device malfunction, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 268 | 26500622 |
DO |
9 | 2 |
Drug dose omission by device, Device malfunction, |
||||
SOMATROPIN, |
||||
| 269 | 26500666 |
US |
||
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 270 | 26500756 |
US |
||
Device use error, Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 271 | 26500786 |
US |
||
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 272 | 26501716 |
US |
35 | 2 |
Device malfunction, |
||||
PEGFILGRASTIM, |
||||
| 273 | 26501807 |
US |
||
Drug dose omission by device, Device delivery system issue, Device malfunction, Product with quality issue administered, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 274 | 26502215 |
US |
14 | 1 |
Device malfunction, Device power source issue, |
||||
SOMATROPIN, SOMATROPIN, SOMATROPIN, |
||||
| 275 | 26502638 |
US |
91 | |
Malaise, Product prescribing issue, Device delivery system issue, Product dose omission issue, Overdose, Product information content complaint, Device malfunction, |
||||
ALBUTEROL SULFATE AND BUDESONIDE, |
||||
| 276 | 26502700 |
US |
||
Surgery, Device malfunction, Incorrect dose administered, |
||||
GUSELKUMAB, GUSELKUMAB, GUSELKUMAB, GUSELKUMAB, |
||||
| 277 | 26502701 |
US |
||
Device malfunction, No adverse event, Device malfunction, No adverse event, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 278 | 26497581 |
US |
||
Off label use, Device delivery system issue, Device malfunction, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALBUTEROL, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, ARIPIPRAZOLE, ALPRAZOLAM, LOSARTAN, CITALOPRAM, CITALOPRAM HYDROBROMIDE, OXYMETAZOLINE HYDROCHLORIDE, |
||||
| 279 | 26497583 |
US |
||
Device delivery system issue, Drug dose omission by device, Device malfunction, Wrong technique in device usage process, Wrong technique in product usage process, Off label use, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 280 | 26497593 |
CA |
66 | |
Adrenal gland cancer, Uterine neoplasm, Device malfunction, Drug dose omission by device, Intentional dose omission, |
||||
ADALIMUMAB-AATY, ADALIMUMAB-AATY, ADALIMUMAB-AATY, ADALIMUMAB-AATY, |
||||
| 281 | 26497788 |
US |
||
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 282 | 26497887 |
US |
||
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 283 | 26496977 |
EU |
||
Device malfunction, Drug delivery system issue, |
||||
| 284 | 26497023 |
US |
||
Injection site pain, Needle track marks, Device malfunction, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 285 | 26497060 |
JP |
||
Product complaint, Device malfunction, Device use issue, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 286 | 26492135 |
US |
70 | |
Wrong technique in product usage process, Device malfunction, Off label use, |
||||
ALBUTEROL SULFATE, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 287 | 26492174 |
US |
58 | 2 |
Device malfunction, Product dose omission issue, Product design issue, |
||||
OCTREOTIDE ACETATE, OCTREOTIDE ACETATE, OCTREOTIDE ACETATE, |
||||
| 288 | 26492208 |
US |
||
Device malfunction, No adverse event, Device malfunction, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 289 | 26492212 |
CO |
30 | 1 |
Hydrocephalus, Neurological infection, Cardiac arrest, Device malfunction, |
||||
| 290 | 26492284 |
US |
||
Device malfunction, Product dose omission issue, |
||||
GOLIMUMAB, GOLIMUMAB, GOLIMUMAB, GOLIMUMAB, |
||||
| 291 | 26492478 |
GB |
82 | |
Dementia, Device malfunction, Product dose omission issue, |
||||
ADALIMUMAB-AATY, ADALIMUMAB-AATY, |
||||
| 292 | 26492572 |
US |
||
No adverse event, Device malfunction, No adverse event, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 293 | 26492834 |
US |
||
Incorrect dose administered, Device malfunction, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 294 | 26492839 |
US |
62 | 2 |
Aortic valve disease, Therapeutic product effect incomplete, Product dose omission issue, Device malfunction, |
||||
METHOTREXATE, IMATINIB MESYLATE, METOPROLOL TARTRATE, METOPROLOL, FOLIC ACID, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, |
||||
| 295 | 26492909 |
US |
||
Device malfunction, |
||||
GUSELKUMAB, GUSELKUMAB, GUSELKUMAB, GUSELKUMAB, |
||||
| 296 | 26492938 |
US |
||
Device malfunction, |
||||
NITRIC OXIDE, |
||||
| 297 | 26492939 |
US |
||
Device malfunction, |
||||
NITRIC OXIDE, |
||||
| 298 | 26493661 |
US |
||
Device malfunction, No adverse event, Device malfunction, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 299 | 26493792 |
US |
||
Device malfunction, Product dose omission issue, Device malfunction, Product dose omission issue, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 300 | 26494011 |
US |
||
Device malfunction, |
||||
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
2026-04-28