Drug:
Reaction: DEVICE BREAKAGE
20260101 - 20261231
No. 101 - 200
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 101 | 26497528 |
2 | ||
Hysterectomy, Implant site scar, Device breakage, Complication associated with device, |
||||
ETONOGESTREL, ETONOGESTREL, |
||||
| 102 | 26497744 |
US |
43 | 2 |
Device breakage, Incorrect dose administered, |
||||
SECUKINUMAB, |
||||
| 103 | 26496676 |
EU |
73 | 2 |
Stoma site infection, Device breakage, Stoma site discharge, Device leakage, Stoma site hypergranulation, Device dislocation, |
||||
SELEGILINE, ROTIGOTINE, TEMAZEPAM, |
||||
| 104 | 26492475 |
US |
1 | |
Cerebrovascular accident, Rhinorrhoea, Dehydration, Mobility decreased, Urinary tract infection, Device breakage, Cough, Memory impairment, Headache, |
||||
PANCRELIPASE, |
||||
| 105 | 26494314 |
US |
1 | |
Respiratory tract infection viral, Respiratory disorder, Device breakage, |
||||
TEDUGLUTIDE, TEDUGLUTIDE, TEDUGLUTIDE, TEDUGLUTIDE, CANNABIDIOL, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, FLUTICASONE PROPIONATE, MONTELUKAST SODIUM, IRON, ERGOCALCIFEROL, VIGABATRIN, TOPIRAMATE, TOPIRAMATE SPINKLE, BACLOFEN, |
||||
| 106 | 26494793 |
US |
||
Device breakage, Device mechanical issue, |
||||
HYDROMORPHONE HYDROCHLORIDE, |
||||
| 107 | 26495679 |
US |
55 | 2 |
Drug dose omission by device, Device breakage, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 108 | 26495943 |
US |
48 | 1 |
Product dose omission issue, Device use error, Device breakage, |
||||
SIBEPRENLIMAB, |
||||
| 109 | 26496204 |
US |
2 | |
Device implantation error, Device breakage, |
||||
LEVONORGESTREL, |
||||
| 110 | 26496346 |
US |
14 | 2 |
Device breakage, Off label use, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 111 | 26485569 |
US |
2 | |
Injury, Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Pain, |
||||
COPPER, |
||||
| 112 | 26486301 |
US |
||
Circumstance or information capable of leading to medication error, Accidental exposure to product, Device breakage, |
||||
GLATIRAMER ACETATE, GLATIRAMER ACETATE, |
||||
| 113 | 26490422 |
US |
27 | 2 |
Surgery, Device breakage, Foreign body in urogenital tract, Complication of device removal, Emotional distress, Complication associated with device, Device dislocation, Abdominal pain, Pelvic pain, Muscle spasms, Dysmenorrhoea, Intermenstrual bleeding, Heavy menstrual bleeding, Dyspareunia, Device expulsion, |
||||
COPPER, |
||||
| 114 | 26491503 |
US |
||
Device breakage, Device leakage, |
||||
CONJUGATED ESTROGENS, ESTROGENS, CONJUGATED, |
||||
| 115 | 26491571 |
US |
1 | |
Device breakage, Circumstance or information capable of leading to medication error, |
||||
SOMATROPIN, |
||||
| 116 | 26481972 |
US |
||
Product use in unapproved indication, Drug dose omission by device, Device delivery system issue, Device breakage, |
||||
OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE, |
||||
| 117 | 26481976 |
US |
||
Product use issue, Drug dose omission by device, Device breakage, Device delivery system issue, Device occlusion, |
||||
OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE, |
||||
| 118 | 26482015 |
US |
29 | 2 |
Product use issue, Wrong technique in device usage process, Device defective, Device breakage, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE, |
||||
| 119 | 26482166 |
US |
||
Product use in unapproved indication, Device breakage, Device delivery system issue, |
||||
OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE, |
||||
| 120 | 26482331 |
US |
||
Drug dose omission by device, Device delivery system issue, Device breakage, Drug effective for unapproved indication, |
||||
OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE, OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE, |
||||
| 121 | 26482595 |
US |
||
Product use in unapproved indication, Drug dose omission by device, Device delivery system issue, Device defective, Device breakage, Device occlusion, |
||||
OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE, |
||||
| 122 | 26482687 |
US |
||
Product use in unapproved indication, Drug dose omission by device, Device breakage, |
||||
OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE, |
||||
| 123 | 26482716 |
US |
||
Product use in unapproved indication, Product use issue, Device delivery system issue, Device breakage, |
||||
OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE, |
||||
| 124 | 26482776 |
US |
||
Drug effective for unapproved indication, Device delivery system issue, Device breakage, Wrong technique in device usage process, Device issue, Product tampering, |
||||
OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE, OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE, |
||||
| 125 | 26482783 |
US |
||
Product prescribing issue, Device use error, Device breakage, Device issue, |
||||
OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE, |
||||
| 126 | 26482929 |
US |
||
Drug dose omission by device, Product use issue, Device delivery system issue, Device breakage, |
||||
OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE, FLUTICASONE PROPIONATE, ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL, |
||||
| 127 | 26483254 |
US |
20 | 2 |
Device breakage, |
||||
SOMATROPIN, |
||||
| 128 | 26483883 |
CO |
2 | |
Device breakage, Device delivery system issue, |
||||
SOMATROPIN, |
||||
| 129 | 26484485 |
US |
||
Device breakage, Pain, |
||||
GEMCITABINE INTRAVESICAL, GEMCITABINE INTRAVESICAL, |
||||
| 130 | 26484946 |
US |
2 | |
Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Pain, |
||||
COPPER, |
||||
| 131 | 26485257 |
US |
68 | 2 |
Arthritis, Arthropathy, Fibromyalgia, Atrial fibrillation, Osteoarthritis, Blood pressure abnormal, Blood cholesterol abnormal, Arthritis, Fall, Device breakage, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 132 | 26477907 |
JP |
46 | 2 |
Uterine adhesions, Embedded device, Device breakage, Complication of device removal, |
||||
LEVONORGESTREL, |
||||
| 133 | 26478048 |
US |
2 | |
Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Pain, Device use issue, Off label use, |
||||
COPPER, |
||||
| 134 | 26479226 |
US |
12 | 2 |
Drug dose omission by device, Device breakage, Device leakage, |
||||
SOMATROPIN, |
||||
| 135 | 26471690 |
US |
||
Drug dose omission by device, Device breakage, Device delivery system issue, Device malfunction, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 136 | 26472301 |
US |
||
Intercepted product preparation error, Device breakage, Product leakage, Wrong technique in product usage process, |
||||
LEUPROLIDE ACETATE, |
||||
| 137 | 26473561 |
47 | 2 | |
Device breakage, Complication of device removal, Uterine leiomyoma, |
||||
LEVONORGESTREL, |
||||
| 138 | 26474018 |
US |
72 | 2 |
Knee arthroplasty, Drug dose omission by device, Incorrect route of product administration, Product label confusion, Off label use, Device use error, Device breakage, Device leakage, |
||||
SOMATROPIN, SOMATROPIN, SOMATROPIN, |
||||
| 139 | 26474918 |
US |
||
Drug effective for unapproved indication, Drug dose omission by device, Device delivery system issue, Device issue, Device breakage, Device occlusion, |
||||
OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE, LISDEXAMFETAMINE DIMESYLATE, SERTRALINE, METHYLPHENIDATE, METHYLPHENIDATE HYDROCHLORIDE, |
||||
| 140 | 26475065 |
US |
||
Product use in unapproved indication, Device delivery system issue, Device breakage, |
||||
OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE, OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE, |
||||
| 141 | 26475218 |
US |
||
Product use in unapproved indication, Product use issue, Drug dose omission by device, Device breakage, Device delivery system issue, |
||||
OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE, OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE, |
||||
| 142 | 26466866 |
US |
43 | |
Device breakage, Device occlusion, |
||||
PLOZASIRAN, OLEZARSEN SODIUM, LOSARTAN POTASSIUM, LOSARTAN, AMLODIPINE, EZETIMIBE, SIMVASTATIN, ISOSORBIDE DINITRATE, EPLERENONE, ICOSAPENT ETHYL, ICOSAPENT ETHYL CAPSULES, CLONIDINE HYDROCHLORIDE, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, PANTOPRAZOLE, |
||||
| 143 | 26467020 |
US |
2 | |
Injury, Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Anxiety, Emotional distress, Pain, |
||||
COPPER, |
||||
| 144 | 26467021 |
US |
2 | |
Injury, Device breakage, Foreign body in reproductive tract, Complication of device removal, Anxiety, Anhedonia, Pain, |
||||
COPPER, |
||||
| 145 | 26467284 |
EU |
2 | |
Device breakage, Device leakage, |
||||
| 146 | 26468018 |
US |
2 | |
Injury, Reproductive complication associated with device, Salpingo-oophorectomy, Device breakage, Foreign body in reproductive tract, Complication of device removal, Emotional distress, Pain, |
||||
COPPER, |
||||
| 147 | 26468563 |
2 | ||
Device breakage, Complication of device removal, |
||||
LEVONORGESTREL, |
||||
| 148 | 26468609 |
US |
11 | 1 |
Drug dose omission by device, Device breakage, Device leakage, |
||||
SOMATROPIN, |
||||
| 149 | 26468647 |
2 | ||
Device breakage, Wrong technique in device usage process, Product prescribing issue, |
||||
LEVONORGESTREL, |
||||
| 150 | 26469505 |
US |
1 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 151 | 26460824 |
US |
57 | |
Neoplasm malignant, Device breakage, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 152 | 26462469 |
US |
||
Incorrect dose administered by device, Device breakage, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 153 | 26462795 |
US |
47 | 2 |
Surgery, Device breakage, Complication of device removal, Foreign body in reproductive tract, Embedded device, Procedural pain, Post procedural haemorrhage, Emotional distress, Dysuria, Muscle spasms, Menstruation irregular, Abdominal pain, Heavy menstrual bleeding, |
||||
COPPER, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, GLIPIZIDE, INSULIN GLARGINE, GABAPENTIN, PANTOPRAZOLE, |
||||
| 154 | 26457631 |
US |
32 | 2 |
Surgery, Device breakage, Foreign body in reproductive tract, Complication of device removal, Embedded device, Procedural pain, Loss of consciousness, Heavy menstrual bleeding, |
||||
COPPER, OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, |
||||
| 155 | 26457632 |
US |
2 | |
Reproductive complication associated with device, Infertility female, Device breakage, Foreign body in reproductive tract, Complication of device removal, Embedded device, Procedural anxiety, Procedural pain, Emotional distress, Anxiety, Sexual dysfunction, Device dislocation, Abdominal pain, Device expulsion, Pelvic pain, Menstruation irregular, Amenorrhoea, |
||||
COPPER, |
||||
| 156 | 26457633 |
US |
2 | |
Surgery, Device breakage, Foreign body in reproductive tract, Complication of device removal, Embedded device, Procedural pain, Flank pain, Suprapubic pain, Depression, Anxiety, Device dislocation, Pelvic pain, Abdominal pain lower, Muscle spasms, Abnormal uterine bleeding, Pain, |
||||
COPPER, |
||||
| 157 | 26458337 |
40 | 2 | |
Device breakage, Device expulsion, Complication of device removal, |
||||
LEVONORGESTREL, |
||||
| 158 | 26458637 |
CO |
2 | |
Device breakage, Device leakage, Administration site acne, Lack of administration site rotation, |
||||
SOMATROPIN, |
||||
| 159 | 26459528 |
CL |
11 | 1 |
Device leakage, Device breakage, |
||||
SOMATROPIN, |
||||
| 160 | 26459738 |
US |
2 | |
Ruptured ectopic pregnancy, Device breakage, Foreign body in reproductive tract, Complication of device removal, |
||||
COPPER, |
||||
| 161 | 26459739 |
US |
2 | |
Laparoscopy, Uterine injury, Device breakage, Foreign body in reproductive tract, Complication of device removal, Embedded device, Depression, Insomnia, Sensation of foreign body, Anxiety, Procedural pain, Pain, Pelvic pain, Device dislocation, Back pain, Abdominal pain lower, |
||||
COPPER, |
||||
| 162 | 26454548 |
US |
23 | 1 |
Vascular device infection, Device breakage, Vomiting, |
||||
TEDUGLUTIDE, TEDUGLUTIDE, TEDUGLUTIDE, TEDUGLUTIDE, |
||||
| 163 | 26454908 |
US |
56 | 2 |
Surgery, Device breakage, Foreign body in reproductive tract, Complication of device removal, Embedded device, |
||||
COPPER, |
||||
| 164 | 26454910 |
US |
2 | |
Hospitalisation, Reproductive complication associated with device, Oophorectomy, Device breakage, Foreign body in reproductive tract, Complication of device removal, Procedural pain, Emotional distress, Pain, Muscle spasms, Abnormal uterine bleeding, Intentional device use issue, Off label use, |
||||
COPPER, |
||||
| 165 | 26454912 |
US |
2 | |
Surgery, Device breakage, Foreign body in reproductive tract, Complication of device removal, Embedded device, Muscle spasms, Device dislocation, Device issue, Emotional distress, Coital bleeding, Procedural haemorrhage, Vaginal discharge, Dyspareunia, Intermenstrual bleeding, Vaginal infection, |
||||
COPPER, CITALOPRAM, CITALOPRAM HYDROBROMIDE, CLINDAMYCIN PHOSPHATE, CLINDAMYCIN, |
||||
| 166 | 26454913 |
US |
30 | 2 |
Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Embedded device, Emotional distress, Menstruation irregular, Abnormal uterine bleeding, Muscle spasms, Pain, Device use issue, Off label use, |
||||
COPPER, LORAZEPAM, |
||||
| 167 | 26454914 |
US |
2 | |
Laparoscopy, Device breakage, Complication of device removal, Foreign body in reproductive tract, Embedded device, Uterine perforation, Emotional distress, Procedural pain, Complication associated with device, Heavy menstrual bleeding, Infection, Discomfort, Pain, Menstruation irregular, Muscle spasms, Abnormal uterine bleeding, Off label use, |
||||
COPPER, LISINOPRIL, |
||||
| 168 | 26456199 |
US |
2 | |
Cough, Product use in unapproved indication, Device breakage, Device malfunction, |
||||
FLUTICASONE PROPIONATE AND SALMETEROL, |
||||
| 169 | 26451014 |
US |
13 | 1 |
Device issue, Device breakage, |
||||
SOMATROPIN, |
||||
| 170 | 26452304 |
KR |
9 | 1 |
Device breakage, Device material issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 171 | 26452770 |
EU |
76 | 1 |
Restlessness, Device breakage, |
||||
FOSCARBIDOPA/FOSLEVODOPA, FOLIC ACID, DABIGATRAN ETEXILATE MESYLATE, DABIGATRAN ETEXILATE, CLOZAPINE, RIVASTIGMINE, |
||||
| 172 | 26441851 |
48 | 2 | |
Device breakage, Abdominal pain lower, Complication of device removal, Genital haemorrhage, |
||||
LEVONORGESTREL, VALSARTAN, VALSARTAN ORAL, |
||||
| 173 | 26443474 |
US |
50 | 2 |
Product dose omission issue, Product use in unapproved indication, Device breakage, Device defective, Device issue, Device delivery system issue, No adverse event, |
||||
LIRAGLUTIDE, LIRAGLUTIDE, |
||||
| 174 | 26443475 |
US |
50 | 2 |
Product dose omission issue, Device breakage, Device issue, Device difficult to use, |
||||
LIRAGLUTIDE, |
||||
| 175 | 26444921 |
US |
2 | |
Device malfunction, Device breakage, |
||||
DICLOFENAC, DICLOFENAC SODIUM, |
||||
| 176 | 26437405 |
US |
2 | |
Injury, Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Emotional distress, Pain, |
||||
COPPER, |
||||
| 177 | 26437406 |
US |
2 | |
Injury, Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Emotional distress, Pain, |
||||
COPPER, |
||||
| 178 | 26437407 |
US |
2 | |
Injury, Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Emotional distress, Pain, |
||||
COPPER, |
||||
| 179 | 26437408 |
US |
2 | |
Injury, Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Emotional distress, Pain, |
||||
COPPER, |
||||
| 180 | 26437409 |
US |
2 | |
Injury, Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Emotional distress, Pain, |
||||
COPPER, |
||||
| 181 | 26437410 |
US |
2 | |
Injury, Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Emotional distress, Pain, |
||||
COPPER, |
||||
| 182 | 26438224 |
US |
1 | |
Circumstance or information capable of leading to device use error, Product availability issue, Device breakage, |
||||
SOMATROPIN, |
||||
| 183 | 26438489 |
US |
35 | 2 |
Device breakage, Complication of device removal, Device use issue, |
||||
LEVONORGESTREL, |
||||
| 184 | 26438721 |
US |
27 | 2 |
Surgery, Device breakage, Foreign body in urogenital tract, Anxiety, Abnormal uterine bleeding, Muscle spasms, Heavy menstrual bleeding, Pelvic pain, Device expulsion, Menstruation irregular, |
||||
COPPER, |
||||
| 185 | 26438722 |
US |
35 | 2 |
Surgery, Device breakage, Foreign body in urogenital tract, Complication of device removal, Embedded device, Anxiety, Emotional distress, Sexual dysfunction, Pain, Dysmenorrhoea, |
||||
COPPER, |
||||
| 186 | 26438723 |
US |
40 | 2 |
Surgery, Device breakage, Foreign body in reproductive tract, Complication of device removal, Embedded device, Emotional distress, Abdominal pain lower, Heavy menstrual bleeding, Device dislocation, Device expulsion, |
||||
COPPER, ESCITALOPRAM, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, |
||||
| 187 | 26438724 |
US |
44 | 2 |
Surgery, Device breakage, Foreign body in reproductive tract, Complication of device removal, Embedded device, Menstruation irregular, Intermenstrual bleeding, Device use issue, Off label use, |
||||
COPPER, ALBUTEROL SULFATE, FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE, METOPROLOL TARTRATE, METOPROLOL, AMLODIPINE, PANTOPRAZOLE, |
||||
| 188 | 26439183 |
US |
||
Off label use, Device breakage, |
||||
EPOPROSTENOL, EPOPROSTENOL, |
||||
| 189 | 26439779 |
US |
2 | |
Injury, Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Emotional distress, Pain, |
||||
COPPER, |
||||
| 190 | 26439780 |
US |
2 | |
Injury, Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Emotional distress, Pain, Device use issue, Off label use, |
||||
COPPER, |
||||
| 191 | 26440235 |
35 | 2 | |
Device breakage, Complication of device insertion, |
||||
LEVONORGESTREL, |
||||
| 192 | 26440618 |
US |
1 | |
Device breakage, |
||||
SOMATROPIN, |
||||
| 193 | 26441011 |
US |
3 | |
Device breakage, Urine output increased, Faecal volume increased, Diarrhoea, Abnormal faeces, Frequent bowel movements, Vomiting, Flatulence, Abdominal distension, Weight increased, Product use complaint, |
||||
TEDUGLUTIDE, TEDUGLUTIDE, TEDUGLUTIDE, TEDUGLUTIDE, |
||||
| 194 | 26441013 |
EU |
68 | 2 |
Wrist fracture, Fall, Device breakage, |
||||
FOSCARBIDOPA/FOSLEVODOPA, |
||||
| 195 | 26432008 |
US |
47 | 2 |
Off label use, No adverse event, Device defective, Device breakage, Product dose omission issue, |
||||
OMALIZUMAB, FREMANEZUMAB-VFRM, SUMATRIPTAN, |
||||
| 196 | 26432976 |
US |
2 | |
Injury, Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Emotional distress, Pain, |
||||
COPPER, |
||||
| 197 | 26433056 |
US |
||
Exposure via skin contact, Device breakage, Product container issue, |
||||
ONABOTULINUMTOXINA, |
||||
| 198 | 26433509 |
US |
5 | 1 |
Device mechanical issue, Device information output issue, Device breakage, |
||||
SOMATROPIN, |
||||
| 199 | 26433731 |
US |
16 | 1 |
Device breakage, |
||||
SOMATROPIN, |
||||
| 200 | 26434523 |
US |
11 | 2 |
Drug dose omission by device, Device use error, Device breakage, |
||||
SOMATROPIN, VILOXAZINE HYDROCHLORIDE, ARIPIPRAZOLE, |
||||
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