Drug:
Reaction: DEVICE BREAKAGE
20260101 - 20261231
No. 201 - 300
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 201 | 26434582 |
2 | ||
Device breakage, Complication of device removal, |
||||
LEVONORGESTREL, |
||||
| 202 | 26435081 |
US |
2 | |
Hysterectomy, Device breakage, Foreign body in reproductive tract, Complication of device removal, Device use issue, Off label use, |
||||
COPPER, |
||||
| 203 | 26426318 |
EU |
78 | 1 |
Fall, Device dislocation, Device breakage, |
||||
| 204 | 26427035 |
US |
||
Device breakage, |
||||
ADALIMUMAB, |
||||
| 205 | 26427192 |
US |
||
Intercepted product preparation error, Device leakage, Device breakage, |
||||
LEUPROLIDE ACETATE, LEUPROLIDE ACETATE, |
||||
| 206 | 26428864 |
CO |
2 | |
Drug dose omission by device, Device defective, Device mechanical issue, Device breakage, |
||||
SOMATROPIN, |
||||
| 207 | 26429688 |
US |
11 | 2 |
Device breakage, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 208 | 26429689 |
US |
18 | 1 |
Device use error, Device power source issue, Device breakage, Device information output issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 209 | 26429712 |
KR |
14 | 1 |
Drug dose omission by device, Device breakage, |
||||
SOMATROPIN, |
||||
| 210 | 26429766 |
US |
2 | |
Injury, Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Pain, |
||||
COPPER, |
||||
| 211 | 26429967 |
US |
2 | |
Pneumonia, Device delivery system issue, Bronchitis, Device defective, Device breakage, Chronic obstructive pulmonary disease, Product dose omission issue, Incorrect dose administered by device, Asthma, Lacrimation increased, Emotional distress, |
||||
| 212 | 26430296 |
46 | 2 | |
Device breakage, Complication of device removal, Device physical property issue, |
||||
LEVONORGESTREL, |
||||
| 213 | 26430848 |
CA |
1 | |
Volvulus, Device breakage, Device dislocation, |
||||
FOSCARBIDOPA/FOSLEVODOPA, ENTACAPONE, RASAGILINE MESYLATE, RASAGILINE, LORATADINE, LORATADINE ORAL, AMANTADINE, CARBIDOPA AND LEVODOPA, |
||||
| 214 | 26423013 |
US |
||
Device difficult to use, Device issue, Product lot number issue, Product expiration date issue, Device breakage, No adverse event, |
||||
RISPERIDONE, |
||||
| 215 | 26424064 |
40 | 2 | |
Device breakage, Uterine leiomyoma, |
||||
LEVONORGESTREL, LEVONORGESTREL, |
||||
| 216 | 26425223 |
CO |
2 | |
Device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 217 | 26425224 |
GB |
16 | 1 |
Device breakage, Device mechanical issue, |
||||
SOMATROPIN, |
||||
| 218 | 26425256 |
US |
5 | 1 |
Device breakage, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 219 | 26419193 |
US |
1 | |
Injury associated with device, Device breakage, |
||||
INSULIN GLARGINE AND LIXISENATIDE, |
||||
| 220 | 26413062 |
US |
2 | |
Injection site mass, Device breakage, Extra dose administered, Device use error, |
||||
SECUKINUMAB, |
||||
| 221 | 26413441 |
US |
||
Device breakage, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 222 | 26413519 |
US |
||
Intentional product use issue, Incorrect dose administered, Device breakage, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 223 | 26413563 |
US |
2 | |
Injury, Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Pain, |
||||
COPPER, |
||||
| 224 | 26413564 |
US |
2 | |
Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Anxiety, Pain, |
||||
COPPER, |
||||
| 225 | 26413565 |
US |
2 | |
Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Anxiety, Pain, |
||||
COPPER, |
||||
| 226 | 26414175 |
US |
80 | 2 |
Muscle spasms, Colitis ulcerative, Device breakage, Drug ineffective, |
||||
RISANKIZUMAB-RZAA, PAROXETINE HYDROCHLORIDE, MESALAMINE, ALBUTEROL SULFATE, TIOTROPIUM BROMIDE AND OLODATEROL, |
||||
| 227 | 26415191 |
US |
59 | 2 |
Nephrolithiasis, Pulmonary mass, Device breakage, Osteopenia, Sinus disorder, Drug hypersensitivity, Diarrhoea, Therapeutic procedure, COVID-19, |
||||
CALCIUM, MAGNESIUM, POTASSIUM, AND SODIUM OXYBATES, CALCIUM, MAGNESIUM, POTASSIUM, AND SODIUM OXYBATES, EVOLOCUMAB, ALIROCUMAB, ESTRADIOL, ESTRADIOL GEL 0.1%, ESTRADIOL TRANSDERMAL, ESTRADIOL,, MODAFINIL, MELOXICAM, CARVEDILOL, SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE, ALBUTEROL SULFATE, MUPIROCIN, MUPIROCIN CALCIUM, ATORVASTATIN CALCIUM, |
||||
| 228 | 26417756 |
US |
1 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 229 | 26407857 |
US |
16 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 230 | 26408575 |
US |
||
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 231 | 26408690 |
US |
1 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 232 | 26408855 |
38 | 2 | |
Obesity, Device breakage, Medical device site injury, Medical device site scar, Abdominal pain upper, Abdominal distension, |
||||
LEVONORGESTREL, |
||||
| 233 | 26410985 |
US |
71 | 1 |
Blood glucose increased, Product dose omission issue, Device breakage, |
||||
INSULIN GLARGINE, |
||||
| 234 | 26411341 |
EU |
75 | 1 |
Asthenia, Device breakage, |
||||
| 235 | 26411978 |
US |
2 | |
Feeling abnormal, Sluggishness, Fatigue, Headache, Product dose omission issue, Device malfunction, Device breakage, |
||||
LIRAGLUTIDE, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, |
||||
| 236 | 26401276 |
US |
1 | |
Fall, Head injury, Balance disorder, Vertigo, Dizziness, Device breakage, |
||||
CARBIDOPA AND LEVODOPA, CARBIDOPA AND LEVODOPA, |
||||
| 237 | 26402814 |
US |
2 | |
Reproductive complication associated with device, Deformity, Device breakage, Foreign body in reproductive tract, Complication of device removal, Anxiety, Pain, Device use issue, Off label use, |
||||
COPPER, |
||||
| 238 | 26402815 |
US |
2 | |
Hysterectomy, Device breakage, Foreign body in reproductive tract, Complication of device removal, Abdominal pain, Abnormal uterine bleeding, |
||||
COPPER, |
||||
| 239 | 26402816 |
US |
2 | |
Reproductive complication associated with device, Deformity, Device breakage, Foreign body in reproductive tract, Complication of device removal, Anxiety, Pain, |
||||
COPPER, |
||||
| 240 | 26402817 |
US |
28 | 2 |
Hysterectomy, Laparoscopy, Device breakage, Foreign body in reproductive tract, Complication of device removal, Embedded device, Infection, Emotional distress, Unevaluable event, Discomfort, Pain, |
||||
COPPER, |
||||
| 241 | 26402818 |
US |
33 | 2 |
Infertility female, Reproductive complication associated with device, Uterine prolapse, Device breakage, Foreign body in reproductive tract, Complication of device removal, Infection, Sexual dysfunction, Emotional distress, Discomfort, Pain, Menstruation irregular, Abnormal uterine bleeding, |
||||
COPPER, |
||||
| 242 | 26404131 |
US |
24 | 1 |
Drug dose omission by device, Wrong technique in device usage process, Device breakage, Device physical property issue, Device leakage, |
||||
SOMATROPIN, |
||||
| 243 | 26405574 |
US |
2 | |
Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Pain, |
||||
COPPER, |
||||
| 244 | 26405575 |
US |
2 | |
Hysterectomy, Device breakage, Foreign body in urogenital tract, Complication of device removal, Embedded device, Vomiting, Abdominal pain, Nausea, Device use issue, Off label use, |
||||
COPPER, |
||||
| 245 | 26405867 |
CH |
67 | 1 |
Device leakage, Device connection issue, Device breakage, Device mechanical issue, |
||||
PEGVISOMANT, |
||||
| 246 | 26397050 |
US |
2 | |
Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Anxiety, Pain, Device use issue, Off label use, |
||||
COPPER, |
||||
| 247 | 26397051 |
US |
2 | |
Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Anxiety, Pain, Device use issue, Off label use, |
||||
COPPER, |
||||
| 248 | 26397052 |
US |
2 | |
Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Anxiety, Pain, |
||||
COPPER, |
||||
| 249 | 26397053 |
US |
37 | 2 |
Laparotomy, Device breakage, Foreign body in reproductive tract, Complication of device removal, Embedded device, Emotional distress, Procedural pain, Pelvic pain, Pain, Device use issue, Off label use, |
||||
COPPER, |
||||
| 250 | 26398387 |
US |
49 | 2 |
Device defective, Injection site mass, Drug dose omission by device, Device breakage, Diabetes mellitus, |
||||
SECUKINUMAB, SECUKINUMAB, |
||||
| 251 | 26399534 |
US |
||
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 252 | 26393513 |
US |
1 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 253 | 26393543 |
US |
28 | 2 |
Device breakage, Complication of device insertion, |
||||
LEVONORGESTREL, |
||||
| 254 | 26393738 |
45 | 2 | |
Device breakage, |
||||
LEVONORGESTREL, |
||||
| 255 | 26394796 |
US |
11 | 1 |
Device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 256 | 26390676 |
US |
14 | 1 |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 257 | 26384945 |
49 | 1 | |
Hospitalisation, Drug withdrawal syndrome, Pain, Renal failure, Drug withdrawal syndrome, Muscle spasticity, Pyrexia, Drug withdrawal syndrome, Muscle spasms, Weight decreased, Device breakage, Muscle atrophy, Device alarm issue, |
||||
BACLOFEN, BACLOFEN, |
||||
| 258 | 26385104 |
US |
2 | |
Reproductive complication associated with device, Deformity, Device breakage, Foreign body in reproductive tract, Complication of device removal, Anxiety, Pain, |
||||
COPPER, |
||||
| 259 | 26385105 |
US |
2 | |
Reproductive complication associated with device, Hysterectomy, Surgery, Device breakage, Foreign body in reproductive tract, Complication of device removal, Embedded device, Uterine perforation, Uterine enlargement, Device material issue, Post procedural haemorrhage, Post-traumatic stress disorder, Emotional distress, Cervix haemorrhage uterine, Impaired work ability, Uterine inflammation, Loss of personal independence in daily activities, Depressed mood, Asthenia, Insomnia, Mood altered, Affect lability, Incisional drainage, Malaise, Depression, Tearfulness, Suprapubic pain, Sexual dysfunction, Choking, Anxiety disorder, Anxiety, Cervix inflammation, Coital bleeding, Menstrual disorder, Pain, Pelvic pain, Dizziness, Discomfort, Intermenstrual bleeding, Heavy menstrual bleeding, Dyspareunia, Abdominal pain, Vaginal discharge, Muscle spasms, Abnormal uterine bleeding, |
||||
COPPER, |
||||
| 260 | 26385106 |
US |
2 | |
Reproductive complication associated with device, Deformity, Device breakage, Foreign body in reproductive tract, Complication of device removal, Anxiety, Pain, |
||||
COPPER, |
||||
| 261 | 26385107 |
US |
2 | |
Reproductive complication associated with device, Deformity, Device breakage, Foreign body in reproductive tract, Complication of device removal, Anxiety, Pain, |
||||
COPPER, |
||||
| 262 | 26385247 |
US |
||
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 263 | 26386261 |
US |
||
Device breakage, Accidental exposure to product, |
||||
| 264 | 26387342 |
US |
1 | 1 |
Drug dependence, Infantile apnoea, Hypoglycaemia, Device information output issue, Device leakage, Device breakage, |
||||
SOMATROPIN, SOMATROPIN, SOMATROPIN, |
||||
| 265 | 26387366 |
US |
33 | 1 |
Drug dose omission by device, Device breakage, |
||||
SOMATROPIN, |
||||
| 266 | 26387802 |
US |
2 | |
Reproductive complication associated with device, Deformity, Device breakage, Foreign body in reproductive tract, Complication of device removal, Anxiety, Pain, |
||||
COPPER, |
||||
| 267 | 26387803 |
US |
2 | |
Injury, Device breakage, Foreign body in reproductive tract, Complication of device removal, Discomfort, Pain, Device use issue, Off label use, |
||||
COPPER, |
||||
| 268 | 26380106 |
US |
67 | 1 |
Cardiac disorder, Device breakage, Osteoarthritis, |
||||
RISANKIZUMAB-RZAA, |
||||
| 269 | 26380132 |
US |
35 | 2 |
Colitis ulcerative, Device breakage, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 270 | 26380451 |
US |
||
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 271 | 26381613 |
US |
||
Device breakage, |
||||
| 272 | 26381713 |
US |
13 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 273 | 26381718 |
US |
||
Device issue, Device breakage, Drug dose omission by device, |
||||
USTEKINUMAB, |
||||
| 274 | 26381774 |
US |
11 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 275 | 26382099 |
EU |
68 | 1 |
Infection, Confusional state, Device breakage, |
||||
FOSCARBIDOPA/FOSLEVODOPA, FOSCARBIDOPA/FOSLEVODOPA, |
||||
| 276 | 26382242 |
US |
1 | |
Device breakage, Circumstance or information capable of leading to medication error, |
||||
SOMATROPIN, |
||||
| 277 | 26382269 |
US |
11 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 278 | 26382309 |
US |
||
Adverse event, Device breakage, |
||||
| 279 | 26382318 |
|||
Product dose omission issue, Product delivery mechanism issue, Device breakage, |
||||
AZELASTINE HYDROCHLORIDE, AZELASTINE, |
||||
| 280 | 26383351 |
US |
1 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 281 | 26383467 |
US |
1 | |
Injection site haemorrhage, Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 282 | 26384110 |
EU |
78 | 2 |
Malaise, Therapeutic product effect incomplete, Loss of personal independence in daily activities, Parkinson^s disease, Hypotension, Feeding disorder, Device breakage, Device issue, Musculoskeletal stiffness, Norovirus infection, Fatigue, Therapeutic product effect incomplete, |
||||
FOSCARBIDOPA/FOSLEVODOPA, FOSCARBIDOPA/FOSLEVODOPA, |
||||
| 283 | 26384240 |
US |
14 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 284 | 26374266 |
US |
1 | |
Device dispensing error, Drug dose omission by device, Device breakage, |
||||
SOMATROPIN, |
||||
| 285 | 26375283 |
US |
50 | 1 |
Eye pain, Accidental exposure to product, Device breakage, |
||||
| 286 | 26375334 |
US |
2 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 287 | 26376265 |
US |
||
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 288 | 26376872 |
US |
1 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 289 | 26378861 |
US |
||
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 290 | 26379313 |
US |
2 | |
Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Emotional distress, Discomfort, Pain, |
||||
COPPER, |
||||
| 291 | 26379409 |
US |
1 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 292 | 26379712 |
US |
||
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 293 | 26379967 |
US |
2 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 294 | 26368807 |
US |
1 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 295 | 26368824 |
US |
2 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, SOMATROPIN, SOMATROPIN, |
||||
| 296 | 26368942 |
US |
1 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 297 | 26369141 |
US |
||
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 298 | 26369160 |
US |
50 | |
Wrong technique in product usage process, Device breakage, |
||||
RISPERIDONE, RISPERIDONE, RISPERIDONE, RISPERIDONE, |
||||
| 299 | 26369214 |
US |
||
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 300 | 26369274 |
US |
1 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
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.
terms
license
last_updated
2026-04-28