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 | 26909287 |
US |
72 | 2 |
Device malfunction, Product leakage, Product dose omission issue, Accidental exposure to product, |
||||
GUSELKUMAB, |
||||
| 202 | 26909398 |
US |
29 | 2 |
Device malfunction, Product dose omission issue, Accidental exposure to product, |
||||
GUSELKUMAB, |
||||
| 203 | 26903936 |
US |
85 | |
Device malfunction, Drug dose omission by device, Incorrect dose administered by device, Device difficult to use, No adverse event, |
||||
TIOTROPIUM BROMIDE, TIOTROPIUM BROMIDE, TIOTROPIUM BROMIDE, |
||||
| 204 | 26904035 |
US |
25 | |
Injection site haemorrhage, Dermatitis atopic, Device malfunction, Extra dose administered, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 205 | 26904269 |
US |
||
Injection site bruising, Device malfunction, |
||||
PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE, |
||||
| 206 | 26904282 |
US |
2 | |
Drug ineffective, Device issue, Device malfunction, |
||||
FREMANEZUMAB-VFRM, |
||||
| 207 | 26903145 |
US |
||
No adverse event, Device malfunction, Device malfunction, No adverse event, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 208 | 26903146 |
US |
||
Device malfunction, Incorrect dose administered by device, Incorrect dose administered by device, Device malfunction, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 209 | 26903195 |
US |
||
No adverse event, Device malfunction, No adverse event, Device malfunction, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 210 | 26903205 |
US |
||
No adverse event, Device malfunction, No adverse event, Device malfunction, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 211 | 26903224 |
US |
||
No adverse event, Device malfunction, Device malfunction, No adverse event, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 212 | 26903242 |
US |
||
No adverse event, Device malfunction, No adverse event, Device malfunction, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 213 | 26903313 |
US |
||
Device malfunction, |
||||
NITRIC OXIDE, NITRIC OXIDE, |
||||
| 214 | 26903337 |
US |
77 | |
Device malfunction, Product dose omission issue, Intentional product use issue, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 215 | 26903570 |
US |
30 | 2 |
Device malfunction, Accidental exposure to product, Drug dose omission by device, Product use in unapproved indication, |
||||
SECUKINUMAB, SECUKINUMAB, |
||||
| 216 | 26897551 |
2 | ||
Injection site haemorrhage, Device malfunction, Incorrect dose administered by device, |
||||
ADALIMUMAB-RYVK, |
||||
| 217 | 26897682 |
US |
||
Circumstance or information capable of leading to medication error, Wrong technique in device usage process, Device difficult to use, Device malfunction, Product quality issue, No adverse event, |
||||
LIRAGLUTIDE, |
||||
| 218 | 26897785 |
US |
2 | |
Asthma, Product dose omission issue, Device malfunction, Device breakage, Device leakage, |
||||
TEZEPELUMAB-EKKO, TEZEPELUMAB-EKKO, |
||||
| 219 | 26897938 |
US |
67 | 2 |
Burning sensation, Accidental exposure to product, Exposure via skin contact, Device malfunction, Injection site pain, |
||||
DUPILUMAB, |
||||
| 220 | 26898292 |
US |
||
Device malfunction, Incorrect dose administered, |
||||
GUSELKUMAB, GUSELKUMAB, |
||||
| 221 | 26898395 |
CA |
73 | |
Haematochezia, Fear of injection, Influenza like illness, Stress, Abdominal pain, Arthralgia, Injection site pain, Exposure via skin contact, Accidental exposure to product, Product administration error, Incorrect dose administered, Intentional dose omission, Overdose, Device malfunction, Inappropriate schedule of product administration, |
||||
INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB, ERGOCALCIFEROL, ROSUVASTATIN, DEXLANSOPRAZOLE, DENOSUMAB, |
||||
| 222 | 26898396 |
US |
71 | 2 |
Unevaluable event, Device malfunction, |
||||
| 223 | 26898634 |
US |
53 | 2 |
Underdose, Accidental exposure to product, Device malfunction, No adverse event, Product dose omission issue, Device malfunction, |
||||
OMALIZUMAB, OMALIZUMAB, ALENDRONATE SODIUM, LISINOPRIL, PREGABALIN, ESTRADIOL, ESTRADIOL GEL 0.1%, ESTRADIOL TRANSDERMAL, ESTRADIOL,, TESTOSTERONE, PROGESTERONE, ERGOCALCIFEROL, |
||||
| 224 | 26898635 |
US |
68 | 2 |
Condition aggravated, Incorrect dose administered, Device malfunction, Skin burning sensation, Dermatitis, Pain of skin, |
||||
SPESOLIMAB-SBZO, SPESOLIMAB, |
||||
| 225 | 26898644 |
US |
47 | 2 |
Product dose omission issue, Product with quality issue administered, Device malfunction, Device physical property issue, No adverse event, Wrong technique in device usage process, Product packaging issue, |
||||
OMALIZUMAB, |
||||
| 226 | 26898655 |
US |
74 | 1 |
Product use issue, Device use error, Device delivery system issue, Wrong technique in product usage process, Device malfunction, |
||||
ALBUTEROL SULFATE AND BUDESONIDE, |
||||
| 227 | 26898767 |
US |
2 | |
Skin indentation, Device malfunction, Product leakage, |
||||
| 228 | 26898798 |
US |
||
No adverse event, Device malfunction, Device malfunction, No adverse event, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 229 | 26898849 |
US |
68 | 2 |
Pain, Off label use, Device malfunction, |
||||
ORAL SEMAGLUTIDE, |
||||
| 230 | 26898862 |
US |
62 | 2 |
Expired product administered, Device malfunction, |
||||
SUMATRIPTAN SUCCINATE, |
||||
| 231 | 26898915 |
US |
54 | 2 |
Product dose omission issue, Device malfunction, Device leakage, Hunger, |
||||
| 232 | 26898927 |
US |
61 | |
Incorrect dose administered, Device malfunction, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 233 | 26898985 |
BR |
68 | 2 |
Chronic obstructive pulmonary disease, Product use issue, Wrong technique in product usage process, Wrong technique in product usage process, Panic disorder, Oxygen saturation decreased, Vomiting, Malaise, Anxiety, Dyspnoea, Treatment noncompliance, Product availability issue, Device malfunction, |
||||
BECLOMETHASONE DIPROPIONATE/FORMOTEROL FUMARATE/GLYCOPYRROLATE, |
||||
| 234 | 26898999 |
US |
95 | |
Product dose omission issue, Device malfunction, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 235 | 26899131 |
US |
36 | |
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 236 | 26899186 |
US |
||
No adverse event, Device malfunction, Device malfunction, No adverse event, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 237 | 26899280 |
US |
67 | |
Product dose omission issue, Device malfunction, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 238 | 26899428 |
US |
||
No adverse event, Device malfunction, No adverse event, Device malfunction, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 239 | 26899432 |
US |
53 | 1 |
Skin pressure mark, Device malfunction, |
||||
| 240 | 26899479 |
US |
53 | |
Cough, Injection site haemorrhage, Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 241 | 26899758 |
US |
18 | 2 |
Injection site haemorrhage, Condition aggravated, Device malfunction, |
||||
DUPILUMAB, |
||||
| 242 | 26899884 |
US |
1 | |
Accident, Paraplegia, Dysphonia, Product quality issue, Circumstance or information capable of leading to device use error, Drug dose omission by device, Device malfunction, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 243 | 26900590 |
US |
36 | 1 |
Device malfunction, Product dose omission issue, No adverse event, |
||||
VEDOLIZUMAB, VEDOLIZUMAB, ALPRAZOLAM, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, |
||||
| 244 | 26901214 |
US |
58 | 2 |
Device malfunction, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, |
||||
| 245 | 26901524 |
US |
22 | |
Rash, Injection site haemorrhage, Device malfunction, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 246 | 26902072 |
US |
91 | |
Product dose omission issue, Device malfunction, Product ineffective for unapproved use, Incorrect dose administered, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 247 | 26902503 |
US |
1 | |
Drug dose omission by device, Device malfunction, |
||||
INSULIN ASPART, |
||||
| 248 | 26902504 |
US |
88 | 1 |
Incorrect dose administered by device, Device malfunction, |
||||
ORAL SEMAGLUTIDE, |
||||
| 249 | 26902505 |
US |
2 | |
Incorrect dose administered by device, Device malfunction, Device leakage, |
||||
| 250 | 26892018 |
US |
2 | |
Drug ineffective, Incorrect dose administered, Device malfunction, |
||||
ALBUTEROL SULFATE, |
||||
| 251 | 26892135 |
|||
Device malfunction, No adverse event, |
||||
RISPERIDONE, |
||||
| 252 | 26892270 |
US |
2 | |
Device malfunction, Hyperhidrosis, Injection site swelling, |
||||
ORAL SEMAGLUTIDE, |
||||
| 253 | 26892661 |
US |
2 | |
Discomfort, Product leakage, Incorrect dose administered, Injection site pain, Device malfunction, |
||||
GUSELKUMAB, |
||||
| 254 | 26892927 |
US |
2 | |
Injection site discharge, Device malfunction, Blister, |
||||
| 255 | 26893010 |
US |
||
Device malfunction, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
| 256 | 26893146 |
US |
83 | 1 |
Wrong technique in device usage process, Hypoacusis, Corrective lens user, Device malfunction, |
||||
ORAL SEMAGLUTIDE, |
||||
| 257 | 26893345 |
US |
2 | |
Weight increased, Drug dose omission by device, Device malfunction, Device leakage, |
||||
| 258 | 26893377 |
US |
14 | |
Product dose omission issue, Device malfunction, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 259 | 26893587 |
CA |
38 | |
Injection site pain, Device malfunction, Muscle contractions involuntary, Incorrect dose administered, |
||||
INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, |
||||
| 260 | 26893749 |
BR |
47 | 1 |
Asthmatic crisis, Seizure, Device malfunction, Off label use, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 261 | 26893954 |
US |
||
Incorrect dose administered by device, Device leakage, Device malfunction, Weight loss poor, Weight increased, |
||||
| 262 | 26895198 |
US |
77 | |
Dermatitis atopic, Pruritus, Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 263 | 26895201 |
US |
34 | |
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 264 | 26895216 |
US |
||
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 265 | 26895226 |
US |
58 | |
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 266 | 26895247 |
US |
23 | |
Device malfunction, Incorrect dose administered, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 267 | 26895261 |
US |
83 | |
Product dose omission issue, Device malfunction, Intentional product use issue, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 268 | 26895266 |
US |
37 | |
Device malfunction, Incorrect dose administered, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 269 | 26895268 |
US |
20 | |
Device malfunction, Incorrect dose administered, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 270 | 26895273 |
US |
69 | |
Product dose omission issue, Device malfunction, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 271 | 26895292 |
US |
51 | |
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 272 | 26895299 |
US |
33 | |
Inappropriate schedule of product administration, Device malfunction, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 273 | 26895303 |
US |
69 | |
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 274 | 26895639 |
US |
68 | 2 |
Dyspnoea, Visual impairment, Memory impairment, Device use error, Needle issue, Product dose omission issue, Drug ineffective, Device physical property issue, Accidental exposure to product, Device malfunction, Device leakage, |
||||
BENRALIZUMAB, BENRALIZUMAB, |
||||
| 275 | 26895726 |
US |
74 | 2 |
Device malfunction, Device mechanical issue, Device delivery system issue, Device deployment issue, |
||||
EPINEPHRINE, ADRENALINUM, |
||||
| 276 | 26896440 |
US |
64 | |
Pruritus, Sleep disorder, Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 277 | 26897165 |
US |
55 | 2 |
Drug dose omission by device, Device malfunction, |
||||
| 278 | 26897167 |
US |
60 | 2 |
Device leakage, Drug dose omission by device, Device malfunction, |
||||
| 279 | 26897168 |
US |
51 | 1 |
Injection site bruising, Injection site discharge, Injection site reaction, Injection site haemorrhage, Incorrect dose administered by device, Injection site pain, Device malfunction, Accidental exposure to product, |
||||
| 280 | 26897169 |
US |
56 | |
Device malfunction, Drug dose omission by device, |
||||
ORAL SEMAGLUTIDE, |
||||
| 281 | 26897170 |
US |
62 | 1 |
Blood glucose increased, Device malfunction, |
||||
ORAL SEMAGLUTIDE, |
||||
| 282 | 26897175 |
US |
1 | |
Blood glucose increased, Drug dose omission by device, Device malfunction, |
||||
ORAL SEMAGLUTIDE, |
||||
| 283 | 26897176 |
US |
2 | |
Device malfunction, Incorrect dose administered by device, |
||||
| 284 | 26897177 |
US |
66 | 2 |
Incorrect dose administered by device, Device malfunction, |
||||
ORAL SEMAGLUTIDE, ORAL SEMAGLUTIDE, |
||||
| 285 | 26897178 |
US |
||
Drug dose omission by device, Device malfunction, |
||||
| 286 | 26897179 |
US |
1 | |
Incorrect dose administered by device, Device malfunction, |
||||
ORAL SEMAGLUTIDE, |
||||
| 287 | 26897181 |
US |
66 | 2 |
Device malfunction, Blood glucose increased, Product storage issue, Device loosening, Device leakage, Wrong technique in device usage process, |
||||
HUMAN INSULIN, |
||||
| 288 | 26897184 |
US |
2 | |
Device malfunction, Drug dose omission by device, |
||||
| 289 | 26897417 |
US |
47 | |
Product dose omission issue, Feeling abnormal, Device malfunction, Needle issue, Incorrect dose administered, |
||||
GUSELKUMAB, |
||||
| 290 | 26886649 |
US |
75 | |
Product dose omission issue, Device malfunction, Accidental exposure to product, Product administration error, |
||||
GUSELKUMAB, |
||||
| 291 | 26886701 |
US |
41 | |
Injection site haemorrhage, Incorrect dose administered, Therapeutic response shortened, Device malfunction, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 292 | 26886784 |
US |
70 | 2 |
Weight increased, Device malfunction, Product dose omission issue, |
||||
| 293 | 26886961 |
US |
||
Product preparation error, Device malfunction, |
||||
LEUPROLIDE ACETATE, |
||||
| 294 | 26887163 |
US |
2 | |
Pneumothorax, Device maintenance issue, Product dose omission issue, Device malfunction, Bronchial secretion retention, Dyspnoea, Condition aggravated, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 295 | 26887349 |
US |
2 | |
Renal disorder, Device malfunction, |
||||
| 296 | 26887485 |
US |
37 | 2 |
Injection site swelling, Abdominal discomfort, Feeling abnormal, Incorrect dose administered by device, Device malfunction, Device leakage, |
||||
ORAL SEMAGLUTIDE, |
||||
| 297 | 26887541 |
US |
2 | |
Injection site haemorrhage, Incorrect dose administered by device, Weight loss poor, Device malfunction, Injection site bruising, Device leakage, |
||||
| 298 | 26887591 |
US |
45 | 2 |
Device use error, Device malfunction, Product dose omission issue, No adverse event, |
||||
OMALIZUMAB, CETIRIZINE HYDROCHLORIDE, |
||||
| 299 | 26888138 |
US |
||
Device malfunction, No adverse event, Device malfunction, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 300 | 26888341 |
US |
||
Device malfunction, |
||||
GUSELKUMAB, |
||||
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
2026-07-30