Drug:
Reaction: DEVICE ISSUE
20260101 - 20261231
No. 201 - 300
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 201 | 26520524 |
US |
33 | 1 |
Gastrointestinal disorder, Device issue, Inappropriate schedule of product administration, Fatigue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 202 | 26521105 |
GB |
1 | |
Fall, Device issue, Stoma site erythema, Device leakage, Device use error, Hallucination, visual, Constipation, |
||||
| 203 | 26512382 |
US |
36 | 1 |
Appendiceal abscess, Appendicitis perforated, Off label use, Diarrhoea, Lethargy, Incorrect dose administered, Device issue, |
||||
VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, |
||||
| 204 | 26512814 |
GB |
71 | 1 |
Hospitalisation, Fall, Dyskinesia, Device issue, Dystonia, Neuropathy peripheral, Back disorder, Hallucination, Constipation, Device breakage, |
||||
OPICAPONE, RASAGILINE MESYLATE, RASAGILINE, |
||||
| 205 | 26512823 |
US |
1 | |
Dyspnoea, Device issue, Device malfunction, |
||||
TIOTROPIUM BROMIDE AND OLODATEROL, |
||||
| 206 | 26513020 |
2 | ||
Device issue, Product dose omission issue, |
||||
TERIPARATIDE, |
||||
| 207 | 26513547 |
US |
1 | |
Injection site haemorrhage, Injection site discharge, Device issue, |
||||
ADALIMUMAB, |
||||
| 208 | 26513972 |
CH |
85 | 1 |
Lumbar vertebral fracture, Device issue, Stoma site discharge, Stoma site hypergranulation, Fall, Stoma site erythema, Confusional state, Hallucination, |
||||
| 209 | 26514100 |
US |
2 | |
Pain in extremity, Breast tenderness, Product adhesion issue, Adhesive tape use, Product administered at inappropriate site, Product storage error, Wrong technique in product usage process, Off label use, Device issue, |
||||
| 210 | 26515523 |
EU |
||
Vasoplegia syndrome, Vertigo, Tremor, Bradycardia, Bradycardia, Hypotension, Headache, Nausea, Chills, Tremor, Headache, Nausea, Chills, Dizziness, Device issue, |
||||
DEGARELIX, DEGARELIX, DEGARELIX, DEGARELIX, ALLOPURINOL, FUROSEMIDE, ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, CANDESARTAN, ENZALUTAMIDE, |
||||
| 211 | 26515574 |
US |
2 | |
Pain, Device use error, Device issue, |
||||
ADALIMUMAB, |
||||
| 212 | 26515682 |
US |
2 | |
Hernia, Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 213 | 26516218 |
US |
75 | 1 |
Device issue, Device defective, Accidental exposure to product, Underdose, Off label use, |
||||
GUSELKUMAB, |
||||
| 214 | 26516273 |
US |
2 | |
Injection site reaction, Device issue, |
||||
ADALIMUMAB, |
||||
| 215 | 26516436 |
US |
1 | |
Seizure, Device issue, Encephalitis, |
||||
ADALIMUMAB, |
||||
| 216 | 26516444 |
US |
6 | 1 |
Device issue, |
||||
SOMATROPIN, |
||||
| 217 | 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, |
||||
| 218 | 26507631 |
US |
||
Device issue, Product administration error, |
||||
PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE, |
||||
| 219 | 26507685 |
US |
51 | 1 |
Deep brain stimulation, Gait inability, On and off phenomenon, Feeling abnormal, Bradykinesia, Sluggishness, Drug ineffective, Tremor, Catheter site pain, Muscular weakness, Malaise, Fatigue, Dysarthria, Dysphagia, Dysstasia, Foot deformity, Gait disturbance, Device issue, Gait disturbance, Balance disorder, Malaise, Catheter site discharge, Catheter site haemorrhage, Dyskinesia, Musculoskeletal stiffness, Therapeutic product effect decreased, On and off phenomenon, Tremor, Anxiety, Stress, Cognitive disorder, Memory impairment, |
||||
FOSCARBIDOPA/FOSLEVODOPA, AMANTADINE, CLONAZEPAM, CITALOPRAM, CITALOPRAM HYDROBROMIDE, |
||||
| 220 | 26507744 |
US |
2 | |
Application site irritation, Application site erythema, Application site pruritus, Product ineffective, Product storage error, Adhesive tape use, Wrong technique in product usage process, Product administered at inappropriate site, Device issue, Product adhesion issue, |
||||
| 221 | 26507814 |
US |
29 | 2 |
Crohn^s disease, Injection site haemorrhage, Injection site bruising, Device issue, Accidental exposure to product, |
||||
GUSELKUMAB, |
||||
| 222 | 26507919 |
US |
23 | 2 |
Surgery, Device issue, Injection site haemorrhage, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 223 | 26507951 |
US |
1 | |
Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 224 | 26508194 |
US |
25 | 2 |
Uterine leiomyoma, Device dislocation, Device issue, Device use error, |
||||
LEVONORGESTREL, |
||||
| 225 | 26508273 |
US |
2 | |
Colitis, Pneumonia, Mental disorder, Brain fog, Traumatic lung injury, Secretion discharge, Anxiety, Cough, Wheezing, Illness, Oropharyngeal pain, Off label use, Accidental underdose, Therapy interrupted, Device issue, |
||||
AMIKACIN, AMIKACIN, AMLODIPINE, METOPROLOL TARTRATE, METOPROLOL, INSULIN HUMAN, |
||||
| 226 | 26508347 |
US |
52 | 2 |
Abdominal discomfort, Device issue, Fatigue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 227 | 26508826 |
2 | ||
Pregnancy with implant contraceptive, Unintended pregnancy, Abortion induced, Device issue, Complication of device removal, Complication associated with device, |
||||
ETONOGESTREL, |
||||
| 228 | 26509508 |
EU |
73 | 1 |
Pneumonia, Underdose, Contraindicated product administered, Hypokinesia, Device use error, Weight decreased, Nasopharyngitis, Decubitus ulcer, Secretion discharge, Akinesia, Dyskinesia, Asthenia, Weight decreased, Hyperkinesia, Psychomotor hyperactivity, Somnolence, Dysarthria, General physical health deterioration, Incorrect dose administered, Device issue, Psychomotor hyperactivity, |
||||
CLINDAMYCIN HYDROCHLORIDE, OXAZEPAM, OXYCODONE, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, BISOPROLOL FUMARATE, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5 PHOSPHATE SODIUM, DEXPANTHENOL AND NIACINAMIDE, PREGABALIN, ROTIGOTINE, DARIFENACIN HYDROBROMIDE, PANTOPRAZOLE, MAGNESIUM, OXYCODONE, MIRTAZAPINE, AMANTADINE, SERTRALINE, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, SIMVASTATIN, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS, AMLODIPINE, CANDESARTAN, |
||||
| 229 | 26509751 |
GB |
2 | |
Device issue, |
||||
DALTEPARIN SODIUM, |
||||
| 230 | 26510290 |
US |
49 | 2 |
Device expulsion, Device issue, |
||||
LEVONORGESTREL, |
||||
| 231 | 26510473 |
36 | ||
Device issue, Accidental exposure to product, Device defective, |
||||
BIMEKIZUMAB, BIMEKIZUMAB, |
||||
| 232 | 26510973 |
US |
58 | 2 |
Product dose omission issue, Device issue, Bronchitis, Aphonia, Memory impairment, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 233 | 26511126 |
US |
1 | |
Ostomy bag placement, Device issue, Injection site urticaria, Injection site pain, Injection site haemorrhage, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 234 | 26511477 |
US |
||
Device issue, Incorrect dose administered by device, |
||||
ESKETAMINE HYDROCHLORIDE, |
||||
| 235 | 26511557 |
US |
2 | |
Device issue, Incorrect dose administered by device, |
||||
OFATUMUMAB, |
||||
| 236 | 26511891 |
US |
15 | 1 |
Device issue, Device mechanical issue, Device breakage, |
||||
SOMATROPIN, |
||||
| 237 | 26512064 |
US |
2 | |
Injection site papule, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 238 | 26512068 |
US |
||
Injection site pain, Device issue, |
||||
FREMANEZUMAB-VFRM, |
||||
| 239 | 26512130 |
US |
55 | |
Device issue, Accidental exposure to product, Product dose omission issue, |
||||
GUSELKUMAB, DULAGLUTIDE, |
||||
| 240 | 26502867 |
US |
2 | |
Chemotherapy, Device issue, Anxiety, |
||||
ADALIMUMAB, |
||||
| 241 | 26502894 |
US |
2 | |
Skin disorder, Device issue, |
||||
FOSCARBIDOPA/FOSLEVODOPA, |
||||
| 242 | 26502986 |
US |
2 | |
Injection site discharge, Device issue, Injection site haemorrhage, |
||||
RISANKIZUMAB-RZAA, |
||||
| 243 | 26503033 |
US |
1 | |
Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 244 | 26503167 |
US |
2 | |
Wrong technique in device usage process, Product storage error, Device issue, Device malfunction, Drug dose omission by device, |
||||
OFATUMUMAB, |
||||
| 245 | 26503403 |
US |
19 | 1 |
Surgery, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 246 | 26503855 |
US |
2 | |
Poor quality device used, Accidental underdose, Device issue, No adverse event, |
||||
| 247 | 26504169 |
US |
63 | 2 |
Drug dose omission by device, Device issue, No adverse event, |
||||
LIRAGLUTIDE, LOSARTAN, FLUOXETINE HYDROCHLORIDE, FLUOXETINE, BUPROPION, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, |
||||
| 248 | 26504181 |
US |
1 | |
Device issue, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
| 249 | 26504276 |
|||
Device issue, Product dose omission issue, |
||||
CERTOLIZUMAB PEGOL, |
||||
| 250 | 26504292 |
US |
1 | |
Device issue, Product dose omission issue, |
||||
| 251 | 26504327 |
AR |
2 | |
Device issue, Product dose omission issue, Drug ineffective, |
||||
GOLIMUMAB, |
||||
| 252 | 26504412 |
US |
82 | 1 |
Condition aggravated, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 253 | 26504476 |
|||
Device issue, |
||||
BIMEKIZUMAB, |
||||
| 254 | 26504487 |
25 | ||
Pain, Device issue, Product dose omission issue, Incorrect dose administered, Product distribution issue, Device defective, Product storage error, |
||||
BIMEKIZUMAB, BIMEKIZUMAB, BIMEKIZUMAB, |
||||
| 255 | 26504497 |
US |
58 | 1 |
Post procedural infection, Tooth extraction, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 256 | 26504528 |
US |
||
Device issue, |
||||
PEGFILGRASTIM, |
||||
| 257 | 26505236 |
US |
46 | 1 |
Device issue, Injection site haemorrhage, |
||||
SECUKINUMAB, |
||||
| 258 | 26505331 |
CO |
20 | 2 |
Headache, Nausea, Discomfort, Accidental overdose, Device issue, |
||||
TREPROSTINIL, TREPROSTINIL, AMBRISENTAN, TADALAFIL, FUROSEMIDE, |
||||
| 259 | 26505740 |
US |
16 | 1 |
Device leakage, Device issue, |
||||
SOMATROPIN, |
||||
| 260 | 26505750 |
US |
16 | 1 |
Drug dose omission by device, Device issue, |
||||
SOMATROPIN, |
||||
| 261 | 26505780 |
EU |
88 | |
Foreign body in eye, Device issue, Anterior chamber cell, |
||||
DEXAMETHASONE, DEXAMETHASONE, |
||||
| 262 | 26506009 |
US |
||
Diverticulitis, Cytokine storm, Cerebrovascular accident, Device issue, Spherocytic anaemia, Asthenia, Chills, Hyperhidrosis, Product dose omission issue, Wrong technique in product usage process, |
||||
RUXOLITINIB, RUXOLITINIB, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, ROMOSOZUMAB-AQQG, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, |
||||
| 263 | 26506276 |
US |
32 | 2 |
Surgery, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 264 | 26506387 |
42 | ||
Product dose omission issue, Device issue, |
||||
BIMEKIZUMAB, |
||||
| 265 | 26506748 |
US |
||
Product dose omission issue, Device issue, Product quality issue, No adverse event, |
||||
OMALIZUMAB, OMALIZUMAB, |
||||
| 266 | 26506803 |
US |
2 | |
Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, |
||||
| 267 | 26506810 |
US |
2 | |
Application site irritation, Application site erythema, Application site pruritus, Product ineffective, Product storage error, Adhesive tape use, Wrong technique in product usage process, Product administered at inappropriate site, Device issue, Product adhesion issue, |
||||
| 268 | 26506873 |
US |
20 | 2 |
Device issue, Needle issue, Accidental exposure to product, Drug dose omission by device, |
||||
SECUKINUMAB, |
||||
| 269 | 26507019 |
US |
1 | |
Injection site haemorrhage, Injection site mass, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 270 | 26507116 |
US |
53 | 1 |
Device issue, Product leakage, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
| 271 | 26507229 |
US |
14 | 1 |
Drug dose omission by device, Device breakage, Device physical property issue, Device issue, |
||||
SOMATROPIN, |
||||
| 272 | 26507508 |
US |
2 | |
Dialysis, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 273 | 26498145 |
US |
1 | |
Product dose omission issue, Device issue, Accidental exposure to product, No adverse event, |
||||
OMALIZUMAB, |
||||
| 274 | 26498149 |
US |
2 | |
Wrong technique in device usage process, Device issue, No adverse event, |
||||
TOCILIZUMAB, |
||||
| 275 | 26498713 |
AR |
49 | 2 |
Wrist fracture, Osteonecrosis, Arthralgia, Bone loss, Device issue, Device leakage, Incorrect dose administered by device, |
||||
OMALIZUMAB, OMALIZUMAB, |
||||
| 276 | 26498869 |
US |
34 | 1 |
Injection site pain, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 277 | 26498904 |
US |
69 | |
Device issue, Needle issue, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
| 278 | 26499427 |
US |
2 | |
Injection site papule, Device issue, |
||||
RISANKIZUMAB-RZAA, |
||||
| 279 | 26499479 |
55 | ||
Accidental exposure to product, Device issue, Device malfunction, Product quality issue, Product dose omission issue, |
||||
BIMEKIZUMAB, |
||||
| 280 | 26499574 |
US |
2 | |
Panic reaction, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 281 | 26499626 |
US |
||
Incorrect dose administered by device, Device issue, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 282 | 26499693 |
US |
||
Device issue, |
||||
TERCONAZOLE, |
||||
| 283 | 26499874 |
US |
||
Device issue, Device leakage, Circumstance or information capable of leading to device use error, No adverse event, |
||||
RISPERIDONE, |
||||
| 284 | 26499890 |
US |
62 | |
Drug dose omission by device, Product container seal issue, Device leakage, Device breakage, Device issue, No adverse event, |
||||
RISPERIDONE, |
||||
| 285 | 26500168 |
US |
2 | |
Wrong technique in product usage process, Adhesive tape use, Product dose omission issue, Product adhesion issue, Device issue, |
||||
| 286 | 26500238 |
US |
2 | |
Crohn^s disease, Device issue, |
||||
RISANKIZUMAB-RZAA, |
||||
| 287 | 26500378 |
AU |
||
Device issue, |
||||
DARUNAVIR, DARUNAVIR, |
||||
| 288 | 26500690 |
US |
2 | |
Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 289 | 26500893 |
US |
2 | |
Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 290 | 26501001 |
US |
17 | 2 |
Device issue, Product dose omission issue, Wrong technique in product usage process, Anxiety, |
||||
GUSELKUMAB, |
||||
| 291 | 26501310 |
22 | ||
Off label use, Device issue, Therapy interrupted, Product availability issue, Incorrect dose administered, |
||||
BIMEKIZUMAB, BIMEKIZUMAB, BIMEKIZUMAB, |
||||
| 292 | 26501352 |
US |
12 | 2 |
Device issue, |
||||
SOMATROPIN, |
||||
| 293 | 26501368 |
CO |
1 | |
Device mechanical issue, Device issue, Device breakage, Drug dose omission by device, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 294 | 26501500 |
EU |
73 | 1 |
Pneumonia, Psychomotor hyperactivity, Nosocomial infection, Akinesia, Secretion discharge, Contraindicated product administered, Hypokinesia, Decubitus ulcer, Hyperkinesia, Weight decreased, Device issue, Asthenia, Incorrect dose administered, Dyskinesia, Dysarthria, Nasopharyngitis, General physical health deterioration, Underdose, Device use error, Somnolence, Psychomotor hyperactivity, |
||||
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, OXYCODONE, CANDESARTAN, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5 PHOSPHATE SODIUM, DEXPANTHENOL AND NIACINAMIDE, PREGABALIN, BISOPROLOL FUMARATE, ROTIGOTINE, AMANTADINE, SIMVASTATIN, OXYCODONE, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS, SERTRALINE, PANTOPRAZOLE, DARIFENACIN HYDROBROMIDE, MIRTAZAPINE, AMLODIPINE, OXAZEPAM, MAGNESIUM, |
||||
| 295 | 26502071 |
US |
55 | 1 |
Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, URSODIOL, URSOSIOL, |
||||
| 296 | 26502204 |
US |
||
Retinal detachment, Device issue, |
||||
DEXAMETHASONE, |
||||
| 297 | 26502747 |
EU |
1 | |
Off label use, Device issue, |
||||
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE, PROPRANOLOL HYDROCHLORIDE, PANTOPRAZOLE SODIUM, PANTOPRAZOLE, PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE, PANTOPRAZOLE SODIUM INJECTION, LEVODOPA, SERTRALINE HYDROCHLORIDE, PRIMIDONE, PRIMIDONE, FOLIC ACID, |
||||
| 298 | 26497582 |
US |
78 | |
Dyspnoea, Device issue, Wrong technique in product usage process, Drug dose omission by device, Off label use, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALBUTEROL SULFATE, LISINOPRIL, OXYBUTYNIN, CHLORTHALIDONE, |
||||
| 299 | 26497704 |
2 | ||
General anaesthesia, Implant site nerve injury, Device issue, Device deployment issue, Complication associated with device, |
||||
ETONOGESTREL, |
||||
| 300 | 26497894 |
AR |
2 | |
Device issue, Product dose omission issue, Off label use, |
||||
GOLIMUMAB, |
||||
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