Drug:
Reaction: DEVICE ISSUE
20250101 - 20251231
No. 201 - 300
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 201 | 25106843 |
JP |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 202 | 25106880 |
US |
2 | |
Fatigue, Headache, Product dose omission issue, Device issue, Device difficult to use, |
||||
SOTATERCEPT-CSRK, SOTATERCEPT-CSRK, SOTATERCEPT-CSRK, SOTATERCEPT-CSRK, MECLIZINE HYDROCHLORIDE, MECLIZINE HCL, MECLIZINE, FUROSEMIDE, ERGOCALCIFEROL, SERTRALINE HYDROCHLORIDE, ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE, ALLOPURINOL, TADALAFIL, OXYGEN, 0XYGEN, ALPRAZOLAM, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PROPRANOLOL HYDROCHLORIDE, CETIRIZINE HCL, CETIRIZINE, PHENOL, GUAIFENESIN, FERROUS SULFATE, |
||||
| 203 | 25106882 |
US |
58 | |
Injection site pain, Wrong technique in device usage process, Device issue, Device delivery system issue, |
||||
TEZEPELUMAB-EKKO, |
||||
| 204 | 25106932 |
IT |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 205 | 25107002 |
CO |
1 | |
Device issue, Poor quality device used, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 206 | 25107050 |
US |
47 | 2 |
Device issue, Product use issue, Device defective, |
||||
ABATACEPT, |
||||
| 207 | 25107220 |
JP |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 208 | 25107336 |
CN |
||
Device issue, Injection site discolouration, |
||||
GUSELKUMAB, |
||||
| 209 | 25107360 |
KR |
||
Needle issue, Device issue, |
||||
GUSELKUMAB, |
||||
| 210 | 25107551 |
US |
70 | 2 |
Intestinal resection, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 211 | 25097402 |
US |
2 | |
Drug dose omission by device, Needle issue, Device delivery system issue, Device issue, |
||||
GLATIRAMER ACETATE, |
||||
| 212 | 25097564 |
US |
1 | |
Device issue, Device leakage, Incorrect dose administered by device, |
||||
SECUKINUMAB, PIOGLITAZONE, GLIPIZIDE, CHLORTHALIDONE, CARVEDILOL, |
||||
| 213 | 25097614 |
US |
11 | 2 |
Product dose omission issue, Accidental exposure to product, Device issue, No adverse event, Product quality issue, Needle issue, Off label use, |
||||
OMALIZUMAB, OMALIZUMAB, BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, ALBUTEROL SULFATE, |
||||
| 214 | 25098200 |
US |
51 | 2 |
Nausea, Flushing, Toothache, Headache, Pain in jaw, Device use error, Patient dissatisfaction with device, Device issue, |
||||
TREPROSTINIL, TREPROSTINIL, TADALAFIL, AMBRISENTAN, FUROSEMIDE, SPIRONOLACTONE, WARFARIN SODIUM, WARFARIN, FLUOXETINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE, SODIUM CHLORIDE, SODIUM CHLORIDE INJECTION, SODIUM CHLORIDE TABLET, NORMAL SALT TABLETS, ALBUTEROL SULFATE, POTASSIUM CHLORIDE, CLONAZEPAM, OXYGEN, 0XYGEN, |
||||
| 215 | 25098210 |
US |
79 | 2 |
Hospitalisation, Dyspnoea, Urticaria, Therapy interrupted, Device issue, Drug dose omission by device, Incorrect dose administered, |
||||
AMIKACIN, AMIKACIN, |
||||
| 216 | 25098677 |
US |
||
Wrong technique in product usage process, Device issue, Device deposit issue, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 217 | 25099148 |
US |
||
Device issue, |
||||
| 218 | 25099509 |
US |
73 | 2 |
Hypotension, Malaise, Injection site discharge, Device issue, Alopecia, |
||||
ONABOTULINUMTOXINA, DUPILUMAB, DUPILUMAB, |
||||
| 219 | 25099885 |
US |
1 | |
Injury associated with device, Skin abrasion, Device issue, |
||||
AFLIBERCEPT, |
||||
| 220 | 25100397 |
US |
34 | 1 |
Product dose omission issue, Device issue, |
||||
ALBUTEROL SULFATE, |
||||
| 221 | 25100511 |
US |
||
Injection site pain, Device issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 222 | 25100541 |
US |
2 | |
Injection site pain, Device issue, |
||||
INSULIN GLARGINE, |
||||
| 223 | 25100720 |
US |
||
Infusion site pain, Infusion site reaction, Illness, Drug tolerance decreased, Device issue, Device occlusion, Device alarm issue, Patient dissatisfaction with device, Device wireless communication issue, Device occlusion, Device issue, Device issue, Device alarm issue, Device wireless communication issue, Device use issue, Device adhesion issue, Device dislocation, |
||||
TREPROSTINIL, |
||||
| 224 | 25100808 |
US |
20 | 2 |
Product administration error, Drug dose omission by device, Device issue, |
||||
MEDROXYPROGESTERONE ACETATE, TESTOSTERONE, TESTOSTERONE,, |
||||
| 225 | 25101159 |
US |
||
Accidental exposure to product, Device difficult to use, Incorrect dose administered by device, Product substitution issue, Device issue, |
||||
TESTOSTERONE, TESTOSTERONE,, TESTOSTERONE, TESTOSTERONE,, TESTOSTERONE, TESTOSTERONE,, |
||||
| 226 | 25101215 |
US |
||
Carbon dioxide increased, Oxygen saturation decreased, Condition aggravated, Drug ineffective, Device issue, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 227 | 25101255 |
GB |
1 | |
Lower respiratory tract infection, Influenza like illness, Nasal congestion, Nasopharyngitis, Device issue, Injection site discharge, Injection site pain, |
||||
OFATUMUMAB, OFATUMUMAB, |
||||
| 228 | 25101275 |
US |
20 | 1 |
Injection site mass, Device issue, |
||||
RISANKIZUMAB-RZAA, ALBUTEROL SULFATE, ALBUTEROL, LORATADINE, LORATADINE TABLET, |
||||
| 229 | 25101357 |
IL |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 230 | 25101497 |
IL |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 231 | 25101637 |
US |
15 | 1 |
Drug dose omission by device, Device mechanical issue, Device issue, |
||||
SOMATROPIN, |
||||
| 232 | 25092182 |
US |
||
Device issue, Product dose omission issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 233 | 25092669 |
AR |
71 | 2 |
Product dose omission issue, Device issue, |
||||
GOLIMUMAB, |
||||
| 234 | 25092880 |
US |
||
No adverse event, Device issue, Syringe issue, |
||||
AVACINCAPTAD PEGOL, AVACINCAPTAD PEGOL, |
||||
| 235 | 25093015 |
IE |
1 | |
Embedded device, Stoma site pain, Device issue, |
||||
ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, SERTRALINE, CARBIDOPA, LEVODOPA, AND ENTACAPONE, ROSUVASTATIN, LACTULOSE, |
||||
| 236 | 25093034 |
US |
55 | 2 |
Device issue, Incorrect dose administered by device, |
||||
SECUKINUMAB, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, LEVOTHYROXINE, |
||||
| 237 | 25093216 |
US |
2 | |
Drug dose omission by device, Device issue, |
||||
PEGFILGRASTIM, |
||||
| 238 | 25093550 |
US |
2 | |
Device issue, Incorrect dose administered by device, Accidental exposure to product, |
||||
OFATUMUMAB, |
||||
| 239 | 25093874 |
US |
85 | |
Pneumonia, COVID-19, Product dose omission issue, Device issue, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 240 | 25094177 |
CO |
2 | |
Device issue, |
||||
SOMATROPIN, |
||||
| 241 | 25094189 |
US |
34 | 1 |
Device issue, Product dose omission issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 242 | 25095418 |
US |
32 | 1 |
Device issue, Product dose omission issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 243 | 25095423 |
US |
12 | 2 |
Device use error, Device issue, Device breakage, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 244 | 25095568 |
US |
1 | |
Device issue, Product dose omission issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 245 | 25095801 |
US |
61 | 1 |
Device issue, Syringe issue, Accidental exposure to product, Product dose omission issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 246 | 25096435 |
DE |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 247 | 25096446 |
JP |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 248 | 25096459 |
JP |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 249 | 25096498 |
FI |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 250 | 25096571 |
JP |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 251 | 25096610 |
AR |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 252 | 25097140 |
US |
70 | 1 |
Injection site bruising, Injection site haemorrhage, Injection site erythema, Injection site swelling, Device issue, Injection site papule, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 253 | 25097156 |
US |
23 | 2 |
Product dose omission issue, Nasopharyngitis, Device issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 254 | 25097192 |
US |
2 | |
Injection site swelling, Injection site induration, Device issue, |
||||
| 255 | 25086752 |
US |
||
Device issue, Incorrect dose administered by device, |
||||
ESKETAMINE HYDROCHLORIDE, |
||||
| 256 | 25086792 |
BR |
44 | 2 |
Pain, Device issue, Product dose omission issue, Device issue, |
||||
GOLIMUMAB, |
||||
| 257 | 25087003 |
US |
1 | |
Device difficult to use, Device issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 258 | 25088891 |
US |
||
Device issue, |
||||
| 259 | 25089034 |
US |
2 | |
Swelling, Skin irritation, Rash, Injection site haemorrhage, Injection site pain, Device issue, |
||||
GLATIRAMER ACETATE, |
||||
| 260 | 25089124 |
CA |
||
Injury associated with device, Device issue, Product leakage, |
||||
| 261 | 25089234 |
US |
14 | 1 |
Device issue, |
||||
SOMATROPIN, |
||||
| 262 | 25089685 |
US |
||
Device issue, |
||||
GUSELKUMAB, GUSELKUMAB, |
||||
| 263 | 25089808 |
US |
11 | 1 |
Device issue, |
||||
SOMATROPIN, |
||||
| 264 | 25090252 |
US |
2 | |
Device issue, Device leakage, Injection site pain, Injection site papule, Needle issue, |
||||
ADALIMUMAB, |
||||
| 265 | 25090291 |
US |
74 | 2 |
Atrial fibrillation, Device issue, |
||||
RISANKIZUMAB-RZAA, |
||||
| 266 | 25090293 |
EG |
11 | 1 |
Device issue, Wrong technique in product usage process, Device use issue, Product preparation error, Expired device used, |
||||
SOMATROPIN, SOMATROPIN, GOSERELIN, |
||||
| 267 | 25090515 |
US |
48 | |
Device issue, Product dose omission issue, |
||||
GUSELKUMAB, GUSELKUMAB, |
||||
| 268 | 25091057 |
CA |
48 | 1 |
Infusion related reaction, Infusion site scar, Needle issue, Fear of injection, Intentional product use issue, Off label use, Malaise, Injection site pruritus, Injection site erythema, Abdominal pain, Infusion site pruritus, Infusion site pain, Hand deformity, Device issue, |
||||
HUMAN IMMUNOGLOBULIN G, HUMAN IMMUNOGLOBULIN G, HUMAN IMMUNOGLOBULIN G, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, |
||||
| 269 | 25091833 |
US |
1 | |
Device difficult to use, Device issue, |
||||
GLATIRAMER ACETATE, |
||||
| 270 | 25091923 |
PL |
||
Incorrect dose administered by device, Device breakage, Device issue, |
||||
SOMATROPIN, |
||||
| 271 | 25091949 |
US |
||
Device issue, Incorrect dose administered, Product dose omission issue, |
||||
ESKETAMINE HYDROCHLORIDE, |
||||
| 272 | 25092003 |
US |
||
Circumstance or information capable of leading to device use error, Device issue, |
||||
ALBUTEROL SULFATE, |
||||
| 273 | 25081747 |
US |
10 | 1 |
Injection site bruising, Device difficult to use, Device issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 274 | 25081862 |
US |
62 | 2 |
Device issue, Incorrect dose administered, Physical product label issue, Accidental exposure to product, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 275 | 25081974 |
US |
||
Injection site papule, Injection site haemorrhage, Needle issue, Incorrect dose administered by device, Device use issue, Extra dose administered, Device delivery system issue, Wrong technique in product usage process, Product label confusion, Device use issue, Device issue, Device malfunction, |
||||
EXENATIDE, EXENATIDE, |
||||
| 276 | 25082296 |
US |
||
Device issue, Product dose omission issue, Incorrect dose administered, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 277 | 25082334 |
US |
1 | |
Injection site papule, Device issue, Injection site haemorrhage, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 278 | 25082471 |
US |
||
Device issue, Device leakage, Product dose omission issue, Tremor, Wound treatment, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 279 | 25082485 |
US |
34 | 2 |
Colectomy, Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Embedded device, Uterine perforation, Device dislocation, Intestinal perforation, Emotional disorder, Sexual dysfunction, Fear, Depression, Device issue, Procedural pain, Pain, Adhesion, Menstrual disorder, |
||||
COPPER, |
||||
| 280 | 25082587 |
EG |
2 | |
Hypoglycaemic coma, Diabetic hyperglycaemic coma, Device issue, |
||||
INSULIN HUMAN, |
||||
| 281 | 25082749 |
IT |
54 | 2 |
Drug dose omission by device, Device occlusion, Device issue, |
||||
SOMATROPIN, |
||||
| 282 | 25082865 |
CO |
||
Device issue, |
||||
| 283 | 25082904 |
US |
15 | 2 |
Product dispensing error, Device issue, No adverse event, |
||||
OMALIZUMAB, OMALIZUMAB, FAMOTIDINE, METHYLPHENIDATE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE, METHYLPHENIDATE, METHYLPHENIDATE, DEXMETHYLPHENIDATE HYDROCHLORIDE, |
||||
| 284 | 25083071 |
US |
27 | 2 |
Unevaluable event, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 285 | 25083332 |
US |
33 | 1 |
Fatigue, Device use issue, Device issue, |
||||
OFATUMUMAB, |
||||
| 286 | 25083673 |
US |
75 | 2 |
Visual impairment, Aphasia, Injection site nodule, Injection site pain, Device issue, Device difficult to use, |
||||
GLATIRAMER ACETATE, GLATIRAMER ACETATE, |
||||
| 287 | 25083779 |
GB |
2 | |
Hospitalisation, Device issue, |
||||
AMIKACIN, |
||||
| 288 | 25084012 |
US |
47 | 1 |
Injection site pain, Injection site swelling, Device issue, |
||||
FREMANEZUMAB-VFRM, |
||||
| 289 | 25084309 |
US |
42 | 2 |
Off label use, Device issue, |
||||
PRAMOXINE HYDROCHLORIDE HYDROCORTISONE ACETATE, PRAMOXINE HYDROCHLORIDE HYDROCORTISONE ACETATE, PRAMOXINE HYDROCHLORIDE HYDROCORTISONE ACETATE, PRAMOXINE HYDROCHLORIDE HYDROCORTISONE ACETATE, |
||||
| 290 | 25084380 |
US |
9 | 2 |
Device issue, Device malfunction, Device leakage, Device use error, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 291 | 25084394 |
US |
11 | 1 |
Poor quality device used, Device leakage, Device issue, Device defective, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 292 | 25084467 |
JP |
62 | 1 |
Acute myeloid leukaemia, COVID-19, Neutrophil count decreased, Platelet count decreased, Device issue, Product outer packaging issue, |
||||
AXICABTAGENE CILOLEUCEL, |
||||
| 293 | 25084532 |
US |
2 | |
Device issue, Product dose omission issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 294 | 25084654 |
US |
||
Device issue, |
||||
PEGFILGRASTIM, |
||||
| 295 | 25084739 |
US |
26 | 1 |
Injection site injury, Device issue, Product quality issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 296 | 25084868 |
US |
78 | 2 |
Oropharyngeal pain, Tinnitus, Perioral dermatitis, Incorrect dose administered, Device difficult to use, Device issue, Wrong technique in product usage process, Circumstance or information capable of leading to medication error, |
||||
TOBRAMYCIN, AZITHROMYCIN, AZITHROMYCIN MONOHYDRATE, AZITHROMYCIN DIHYDRATE, VITAMIN C, CALCIUM, FAMOTIDINE, OIL, BIOTIN, HAIR, CYCLOSPORINE, LEVOTHYROXINE SODIUM, |
||||
| 297 | 25085180 |
US |
||
Device dispensing error, Device delivery system issue, Device issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 298 | 25085727 |
US |
||
Device issue, |
||||
PEGFILGRASTIM, |
||||
| 299 | 25085741 |
US |
25 | 2 |
Appendicitis, Implant site thrombosis, Menstruation delayed, Dysmenorrhoea, Depression, Mood swings, Hyperphagia, Implant site pain, Implant site pruritus, Device placement issue, Device issue, Complication associated with device, Product prescribing issue, Incorrect product administration duration, |
||||
ETONOGESTREL, ETONOGESTREL, ETONOGESTREL, |
||||
| 300 | 25086593 |
US |
||
Device issue, Drug ineffective, Prescription drug used without a prescription, |
||||
ALBUTEROL SULFATE, |
||||
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