Drug:
Reaction: DEVICE BREAKAGE
20260101 - 20261231
No. 1 - 100
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 1 | 26555542 |
GB |
30 | 2 |
Lower respiratory tract infection, Influenza like illness, Chills, Pain in extremity, Influenza like illness, Chills, Pain in extremity, Influenza like illness, Device defective, Needle issue, Device breakage, Device leakage, Chills, Body temperature abnormal, Electric shock sensation, Influenza, Pharyngitis, Urinary tract infection, |
||||
OFATUMUMAB, OFATUMUMAB, OFATUMUMAB, OFATUMUMAB, |
||||
| 2 | 26558552 |
US |
||
Drug dose omission by device, Device breakage, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 3 | 26559604 |
US |
11 | 2 |
Device breakage, Device mechanical issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 4 | 26561100 |
US |
14 | 1 |
Device mechanical issue, Device breakage, |
||||
SOMATROGON-GHLA, |
||||
| 5 | 26561118 |
US |
12 | 1 |
Device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 6 | 26551532 |
US |
38 | 2 |
Surgery, Device breakage, Foreign body in reproductive tract, Complication of device removal, Emotional distress, Stress, Procedural pain, Muscle spasms, Abnormal uterine bleeding, |
||||
COPPER, ACETAZOLAMIDE SODIUM, ACETAZOLAMIDE, |
||||
| 7 | 26552235 |
CA |
73 | 1 |
Cataract, Diarrhoea, Device breakage, |
||||
RISANKIZUMAB-RZAA, |
||||
| 8 | 26569508 |
62 | 1 | |
Euglycaemic diabetic ketoacidosis, Therapy interrupted, Malaise, Device breakage, |
||||
EMPAGLIFLOZIN, INSULIN GLARGINE-YFGN, INSULIN GLARGINE, INSULIN ASPART, |
||||
| 9 | 26549782 |
US |
||
Dyspnoea, Device breakage, Device malfunction, |
||||
ALBUTEROL SULFATE, |
||||
| 10 | 26543317 |
US |
||
Intercepted product preparation error, Wrong technique in product usage process, Device leakage, Device breakage, |
||||
LEUPROLIDE ACETATE, |
||||
| 11 | 26545397 |
US |
12 | 1 |
Device breakage, Device leakage, |
||||
SOMATROPIN, CLONIDINE, LISDEXAMFETAMINE DIMESYLATE, |
||||
| 12 | 26545444 |
US |
56 | 2 |
Drug dose omission by device, Device breakage, Device material issue, |
||||
SOMATROPIN, |
||||
| 13 | 26545470 |
KR |
12 | 1 |
Device breakage, Device use error, Device material issue, |
||||
SOMATROPIN, |
||||
| 14 | 26545482 |
CA |
43 | 1 |
Device breakage, |
||||
PEGVISOMANT, PEGVISOMANT, PEGVISOMANT, PEGVISOMANT, AMLODIPINE, |
||||
| 15 | 26545815 |
US |
2 | |
Injury, Deformity, Device breakage, Foreign body in reproductive tract, Complication of device removal, Anxiety, Emotional distress, Pain, Device use issue, Off label use, |
||||
COPPER, |
||||
| 16 | 26545963 |
|||
Device breakage, Product dose omission issue, |
||||
MIDAZOLAM, |
||||
| 17 | 26546589 |
US |
27 | 2 |
Laparoscopy, Device breakage, Foreign body in reproductive tract, Complication of device removal, Embedded device, Anxiety, Emotional distress, Procedural pain, |
||||
COPPER, |
||||
| 18 | 26536260 |
US |
46 | 2 |
Dyspnoea, Device dislocation, Device breakage, |
||||
TREPROSTINIL, TREPROSTINIL, FUROSEMIDE, POTASSIUM CHLORIDE, POTASSIUM CHLORIDE EXTENDED-RELEASE, POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE, POTASSIUM CHLORIDE ORAL, TADALAFIL, KETAMINE HYDROCHLORIDE, CLONIDINE, KETOPROFEN, LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE ANHYDROUS, AMITRIPTYLINE HYDROCHLORIDE, GABAPENTIN, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS, |
||||
| 19 | 26536264 |
US |
78 | 2 |
Device breakage, Drug dose omission by device, |
||||
INTERFERON BETA-1A, INTERFERON BETA-1A, INTERFERON BETA-1A, INTERFERON BETA-1A, INTERFERON BETA-1A, |
||||
| 20 | 26536361 |
US |
2 | |
Off label use, Device breakage, |
||||
LEUPROLIDE ACETATE, LEUPROLIDE ACETATE, |
||||
| 21 | 26537055 |
US |
2 | |
Deformity, Device breakage, Foreign body in reproductive tract, Complication of device removal, Anxiety, Pain, |
||||
COPPER, |
||||
| 22 | 26537613 |
CA |
||
Device breakage, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 23 | 26538827 |
CL |
||
Device breakage, |
||||
SOMATROPIN, |
||||
| 24 | 26538852 |
US |
||
Device breakage, |
||||
SOMATROPIN, |
||||
| 25 | 26539051 |
US |
48 | 2 |
Device breakage, Complication of device removal, |
||||
LEVONORGESTREL, |
||||
| 26 | 26540616 |
US |
||
Device breakage, Injury associated with device, Drug dose omission by device, |
||||
MEDROXYPROGESTERONE ACETATE, |
||||
| 27 | 26541181 |
CL |
9 | 2 |
Device material issue, Device breakage, |
||||
SOMATROPIN, |
||||
| 28 | 26531405 |
US |
77 | |
Device breakage, Product dose omission issue, No adverse event, |
||||
TESTOSTERONE GEL, 1%, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, CLOPIDOGREL, CLOPIDOGREL BISULFATE, LOSARTAN POTASSIUM, LOSARTAN, EMPAGLIFLOZIN, ROSUVASTATIN CALCIUM, |
||||
| 29 | 26533454 |
US |
55 | 1 |
Inappropriate schedule of product administration, Device breakage, |
||||
| 30 | 26533991 |
US |
10 | 1 |
Drug dose omission by device, Device breakage, Device delivery system issue, Device information output issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 31 | 26534577 |
61 | 1 | |
Pancreatic cyst, Infection, Device breakage, |
||||
| 32 | 26528466 |
US |
2 | |
Device breakage, No adverse event, |
||||
MEDROXYPROGESTERONE ACETATE, |
||||
| 33 | 26528650 |
EU |
52 | 1 |
Pneumothorax, Visual impairment, Restlessness, Gastrointestinal pain, Nocturia, Balance disorder, Loss of personal independence in daily activities, Aphasia, Parkinsonian gait, Restlessness, Pollakiuria, Parkinsonian gait, Dyschezia, Memory impairment, Device use issue, Gastrointestinal stoma complication, Dystonia, Muscle spasms, Weight decreased, Abnormal dreams, Insomnia, Stoma site discharge, Stoma site discharge, Dyskinesia, Therapeutic product effect incomplete, Dizziness, Orthostatic hypotension, Dizziness, Insomnia, Abnormal dreams, Stoma site discharge, Dyskinesia, Stoma site inflammation, Hyperkinesia, Middle insomnia, Bradykinesia, Unevaluable event, Hallucination, Medical device site scab, Hallucination, visual, Stoma site erythema, Stoma site irritation, Fall, Musculoskeletal chest pain, Unevaluable event, Peroneal nerve palsy, Muscle rigidity, Psychomotor hyperactivity, Head discomfort, Device breakage, Gait disturbance, Stoma site discharge, Somnolence, Poor quality sleep, Hunger, Brain fog, Device issue, Micturition urgency, Device power source issue, Device issue, Device connection issue, Fall, Pain, Mobility decreased, |
||||
| 34 | 26528926 |
US |
||
Chest discomfort, Drug dose omission by device, Device breakage, Device delivery system issue, Product container seal issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 35 | 26529515 |
US |
2 | |
Device breakage, Off label use, |
||||
SOMATROPIN, SOMATROPIN, SOMATROPIN, |
||||
| 36 | 26529692 |
41 | 2 | |
Device breakage, Complication of device insertion, |
||||
LEVONORGESTREL, LEVONORGESTREL, |
||||
| 37 | 26530498 |
CO |
2 | |
Device breakage, Device leakage, Device deployment issue, Wrong technique in device usage process, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 38 | 26531099 |
BR |
84 | 2 |
Pelvic fracture, Infusion site pain, Device breakage, Pyrexia, |
||||
| 39 | 26524694 |
US |
2 | |
Device breakage, |
||||
SOMATROPIN, |
||||
| 40 | 26524695 |
EU |
80 | 2 |
Device breakage, |
||||
ESTRADIOL, ESTRADIOL GEL 0.1%, ESTRADIOL TRANSDERMAL, ESTRADIOL,, |
||||
| 41 | 26524718 |
US |
||
Device breakage, |
||||
SOMATROPIN, |
||||
| 42 | 26524956 |
US |
2 | 1 |
Device breakage, Device leakage, |
||||
SOMATROPIN, |
||||
| 43 | 26524960 |
US |
2 | 1 |
Device breakage, Device leakage, |
||||
SOMATROPIN, |
||||
| 44 | 26524976 |
US |
68 | 1 |
Device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 45 | 26525386 |
US |
52 | 1 |
Device breakage, |
||||
SOMATROPIN, |
||||
| 46 | 26525403 |
AR |
6 | 2 |
Device breakage, Intentional dose omission, |
||||
SOMATROPIN, SOMATROPIN, SOMATROPIN, |
||||
| 47 | 26525864 |
2 | ||
Device breakage, Complication of device removal, |
||||
LEVONORGESTREL, |
||||
| 48 | 26517472 |
68 | ||
Haemoglobin decreased, Device breakage, Device issue, |
||||
METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, |
||||
| 49 | 26517477 |
53 | ||
Blood glucose abnormal, Product dose omission issue, Product availability issue, Device breakage, |
||||
| 50 | 26517512 |
55 | ||
Glycosylated haemoglobin increased, Device delivery system issue, Device breakage, Device mechanical issue, Product use issue, |
||||
| 51 | 26517804 |
US |
1 | |
Dysphagia, Device breakage, Hiatus hernia, |
||||
FOSCARBIDOPA/FOSLEVODOPA, FOSCARBIDOPA/FOSLEVODOPA, |
||||
| 52 | 26518487 |
US |
1 | |
Device breakage, |
||||
SUMATRIPTAN SUCCINATE, |
||||
| 53 | 26518488 |
US |
2 | |
Device breakage, Device leakage, |
||||
SUMATRIPTAN SUCCINATE, |
||||
| 54 | 26518649 |
US |
49 | |
Wheezing, Wrong technique in product usage process, Drug dose omission by device, Device breakage, |
||||
LEVALBUTEROL TARTRATE, RIVAROXABAN, BUDESONIDE, GABAPENTIN, |
||||
| 55 | 26519770 |
US |
2 | |
Disability, Device breakage, Foreign body in reproductive tract, Complication of device removal, Embedded device, Anxiety, Pain, |
||||
COPPER, |
||||
| 56 | 26519808 |
US |
4 | 2 |
Device breakage, Device mechanical issue, |
||||
SOMATROPIN, SOMATROPIN, SOMATROPIN, |
||||
| 57 | 26519834 |
US |
12 | 1 |
Device breakage, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 58 | 26512364 |
US |
2 | |
Device breakage, |
||||
DARATUMUMAB AND HYALURONIDASE-FIHJ (HUMAN RECOMBINANT), |
||||
| 59 | 26512477 |
US |
2 | |
Device breakage, Weight increased, Diarrhoea, |
||||
TREPROSTINIL, SOTATERCEPT-CSRK, |
||||
| 60 | 26512814 |
GB |
71 | 1 |
Hospitalisation, Fall, Dyskinesia, Device issue, Dystonia, Neuropathy peripheral, Back disorder, Hallucination, Constipation, Device breakage, |
||||
OPICAPONE, RASAGILINE MESYLATE, RASAGILINE, |
||||
| 61 | 26512968 |
US |
50 | 2 |
Dyspnoea, Device infusion issue, Device leakage, Device breakage, |
||||
TREPROSTINIL, TREPROSTINIL, POTASSIUM CHLORIDE, POTASSIUM CHLORIDE EXTENDED-RELEASE, POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE, POTASSIUM CHLORIDE ORAL, RIVAROXABAN, OXYCODONE HYDROCHLORIDE, OXYCODONE, BUMETANIDE, EMPAGLIFLOZIN, SODIUM CHLORIDE, SODIUM CHLORIDE TABLET, SODIUM CHLORIDE TABLETS, METOLAZONE, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATED, SILDENAFIL CITRATE, SILDENAFIL, OXYGEN, 0XYGEN, ERGOCALCIFEROL, CALCITRIOL, CALCITRIOL CAPSULES 0.25 MCG, CALCITRIOL CAPSULES 0.5 MCG, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, PREGABALIN, |
||||
| 62 | 26514797 |
US |
31 | 2 |
Device breakage, Complication of device removal, |
||||
LEVONORGESTREL, |
||||
| 63 | 26514837 |
2 | ||
Embedded device, Device breakage, |
||||
LEVONORGESTREL, |
||||
| 64 | 26516453 |
AR |
9 | 1 |
Device breakage, Device deployment issue, |
||||
SOMATROPIN, |
||||
| 65 | 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, |
||||
| 66 | 26509010 |
US |
81 | 1 |
Intercepted product preparation error, Device breakage, Device leakage, |
||||
LEUPROLIDE ACETATE, LEUPROLIDE ACETATE, |
||||
| 67 | 26509152 |
US |
2 | |
Device defective, Device breakage, |
||||
BUDESONIDE, |
||||
| 68 | 26509193 |
US |
39 | 2 |
Surgery, Device breakage, Foreign body in reproductive tract, Complication of device removal, Embedded device, Anxiety, Post-traumatic stress disorder, Swelling, Device material issue, Procedural pain, Dysuria, Intentional device use issue, Off label use, Pain, Abnormal uterine bleeding, Back pain, Muscle spasms, |
||||
COPPER, |
||||
| 69 | 26509194 |
US |
38 | 2 |
Reproductive complication associated with device, Laparoscopy, Infertility female, Device breakage, Foreign body in reproductive tract, Complication of device removal, Embedded device, Emotional distress, Procedural pain, Infection, Unevaluable event, |
||||
COPPER, |
||||
| 70 | 26509195 |
US |
36 | 2 |
Surgery, Device breakage, Foreign body in urogenital tract, Complication of device removal, Embedded device, Post procedural haemorrhage, Procedural pain, Emotional distress, Heavy menstrual bleeding, Pelvic pain, Pain, |
||||
COPPER, |
||||
| 71 | 26509196 |
US |
32 | 2 |
Hydrosalpinx, Salpingectomy, Device breakage, Complication of device removal, Pelvic inflammatory disease, Complication associated with device, Risk of future pregnancy miscarriage, Infection, Sexual dysfunction, Anxiety, Emotional distress, Pain, Discomfort, |
||||
COPPER, SPIRONOLACTONE, |
||||
| 72 | 26509197 |
US |
36 | 2 |
Infertility female, Reproductive complication associated with device, Abortion spontaneous, Device breakage, Complication of device removal, Menstruation irregular, Complication of pregnancy, |
||||
COPPER, |
||||
| 73 | 26509198 |
US |
24 | 2 |
Ovarian germ cell teratoma benign, Device breakage, Foreign body in reproductive tract, Complication of device removal, Emotional distress, Procedural dizziness, Heavy menstrual bleeding, Device expulsion, Unevaluable event, |
||||
COPPER, PROPRANOLOL HYDROCHLORIDE, |
||||
| 74 | 26509547 |
US |
28 | 2 |
Reproductive complication associated with device, Device breakage, Foreign body in urogenital tract, Complication of device removal, Embedded device, Emotional distress, Anxiety, Abnormal uterine bleeding, |
||||
COPPER, |
||||
| 75 | 26510079 |
US |
||
Injury associated with device, Device safety feature issue, Device breakage, Syringe issue, Device failure, |
||||
ENOXAPARIN SODIUM, |
||||
| 76 | 26510149 |
CN |
||
Device breakage, |
||||
| 77 | 26510738 |
US |
14 | 1 |
Device breakage, Device leakage, |
||||
SOMATROPIN, |
||||
| 78 | 26511079 |
US |
62 | 2 |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
VARENICLINE, |
||||
| 79 | 26511759 |
US |
12 | 1 |
Device breakage, Device material issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 80 | 26511763 |
KR |
11 | 1 |
Drug dose omission by device, Device use error, Poor quality device used, Device breakage, Device material issue, |
||||
SOMATROPIN, |
||||
| 81 | 26511764 |
US |
14 | 1 |
Sports injury, Lower limb fracture, Ankle fracture, Fall, Device use error, Device breakage, |
||||
SOMATROPIN, SOMATROPIN, SOMATROPIN, SOMATROPIN, |
||||
| 82 | 26511891 |
US |
15 | 1 |
Device issue, Device mechanical issue, Device breakage, |
||||
SOMATROPIN, |
||||
| 83 | 26512145 |
EU |
71 | 1 |
Back pain, Device breakage, Device dislocation, |
||||
| 84 | 26504626 |
US |
32 | 2 |
Reproductive complication associated with device, Surgery, Device breakage, Foreign body in reproductive tract, Complication of device removal, Embedded device, Coital bleeding, Heavy menstrual bleeding, Intermenstrual bleeding, Menstrual disorder, Pain, Abnormal uterine bleeding, Vaginal discharge, Device expulsion, |
||||
COPPER, |
||||
| 85 | 26504627 |
US |
36 | 2 |
Surgery, Device breakage, Foreign body in reproductive tract, Complication of device removal, Anxiety, Post-traumatic stress disorder, Sexual dysfunction, Muscle spasms, Device expulsion, Menstrual disorder, |
||||
COPPER, |
||||
| 86 | 26505503 |
US |
1 | |
Device use issue, Device breakage, |
||||
SOMATROPIN, |
||||
| 87 | 26505733 |
KR |
11 | 2 |
Incorrect dose administered by device, Device leakage, Device breakage, Device material issue, |
||||
SOMATROPIN, |
||||
| 88 | 26505735 |
US |
14 | 1 |
Drug dose omission by device, Device breakage, Device mechanical issue, Device leakage, |
||||
SOMATROPIN, |
||||
| 89 | 26505742 |
US |
15 | 1 |
Device breakage, |
||||
SOMATROPIN, |
||||
| 90 | 26505756 |
CO |
1 | |
Drug dose omission by device, Device breakage, Device material issue, |
||||
SOMATROPIN, |
||||
| 91 | 26505760 |
GB |
11 | 2 |
Device breakage, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 92 | 26505765 |
AR |
10 | 2 |
Device use error, Device breakage, Drug dose omission by device, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 93 | 26506180 |
US |
2 | |
Surgery, Device breakage, Foreign body in urogenital tract, Complication of device removal, Embedded device, Menstrual disorder, Device expulsion, |
||||
COPPER, |
||||
| 94 | 26506812 |
US |
||
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 95 | 26507229 |
US |
14 | 1 |
Drug dose omission by device, Device breakage, Device physical property issue, Device issue, |
||||
SOMATROPIN, |
||||
| 96 | 26499890 |
US |
62 | |
Drug dose omission by device, Product container seal issue, Device leakage, Device breakage, Device issue, No adverse event, |
||||
RISPERIDONE, |
||||
| 97 | 26501095 |
US |
2 | |
Symptom recurrence, Device breakage, |
||||
ADALIMUMAB, |
||||
| 98 | 26501368 |
CO |
1 | |
Device mechanical issue, Device issue, Device breakage, Drug dose omission by device, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 99 | 26502212 |
CL |
11 | 2 |
Device breakage, |
||||
SOMATROPIN, |
||||
| 100 | 26502213 |
US |
16 | 1 |
Drug dose omission by device, 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.
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last_updated
2026-04-28