Drug:
Reaction: DEVICE BREAKAGE
20260101 - 20261231
No. 601 - 700
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 601 | 26299180 |
US |
2 | |
Injury, Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Emotional distress, Pain, |
||||
COPPER, |
||||
| 602 | 26299181 |
US |
2 | |
Injury, Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Emotional distress, Pain, |
||||
COPPER, |
||||
| 603 | 26299182 |
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, |
||||
| 604 | 26299185 |
US |
2 | |
Injury, Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Emotional distress, Pain, |
||||
COPPER, |
||||
| 605 | 26299186 |
US |
2 | |
Injury, Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Emotional distress, Pain, |
||||
COPPER, |
||||
| 606 | 26299767 |
CA |
71 | 2 |
Fall, Device breakage, Shoulder fracture, |
||||
VEDOLIZUMAB, VEDOLIZUMAB, BUDESONIDE, |
||||
| 607 | 26299826 |
US |
63 | 1 |
Pulmonary embolism, Muscular weakness, Throat tightness, Dyspnoea, Fatigue, Product dose confusion, Inappropriate schedule of product administration, Device use issue, Device breakage, Device malfunction, |
||||
SOMATROPIN, FAMOTIDINE, MODAFINIL, ROPINIROLE HYDROCHLORIDE, CARBIDOPA AND LEVODOPA, CARBIDOPA AND LEVODOPA, ERGOCALCIFEROL, GLYCOPYRROLATE, ALBUTEROL SULFATE, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATED, AMANTADINE, |
||||
| 608 | 26301056 |
US |
2 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 609 | 26301057 |
US |
1 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 610 | 26293072 |
US |
1 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 611 | 26293097 |
US |
1 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 612 | 26293242 |
US |
2 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 613 | 26293260 |
US |
1 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 614 | 26293708 |
US |
2 | |
Injury, Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Emotional distress, Pain, |
||||
COPPER, |
||||
| 615 | 26293709 |
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, |
||||
| 616 | 26293710 |
US |
2 | |
Injury, Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Emotional distress, Pain, |
||||
COPPER, |
||||
| 617 | 26293711 |
US |
2 | |
Injury, Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Emotional distress, Pain, |
||||
COPPER, |
||||
| 618 | 26293712 |
US |
2 | |
Injury, Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Emotional distress, Pain, |
||||
COPPER, |
||||
| 619 | 26293713 |
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, |
||||
| 620 | 26293714 |
US |
2 | |
Injury, Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Emotional distress, Pain, |
||||
COPPER, |
||||
| 621 | 26295300 |
US |
76 | 2 |
Femur fracture, Periprosthetic fracture, Device breakage, |
||||
DENOSUMAB, ERGOCALCIFEROL, ACETAMINOPHEN, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, SODIUM CHLORIDE, SODIUM CHLORIDE TABLET, SODIUM CHLORIDE TABLETS, APIXABAN, LOVASTATIN, AMOXICILLIN, HYDROCHLOROTHIAZIDE, FUROSEMIDE, DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS, CARBOXYMETHYLCELLULOSE SODIUM, |
||||
| 622 | 26296391 |
US |
12 | 1 |
Device mechanical issue, Device breakage, |
||||
SOMATROPIN, |
||||
| 623 | 26296506 |
US |
24 | 1 |
Device use error, Device breakage, Device material issue, |
||||
SOMATROPIN, |
||||
| 624 | 26296509 |
US |
14 | 1 |
Drug dose omission by device, Device breakage, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 625 | 26296511 |
US |
15 | 1 |
Product communication issue, Off label use, Device breakage, Device leakage, Device use error, Device material issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 626 | 26296535 |
US |
7 | 1 |
Device breakage, |
||||
SOMATROPIN, |
||||
| 627 | 26296565 |
KR |
13 | 1 |
Drug dose omission by device, Device mechanical issue, Device breakage, |
||||
SOMATROPIN, |
||||
| 628 | 26296566 |
US |
13 | 1 |
Drug dose omission by device, Device breakage, Device difficult to use, |
||||
SOMATROPIN, |
||||
| 629 | 26296567 |
US |
13 | 2 |
Incorrect dose administered by device, Device breakage, Device leakage, |
||||
SOMATROPIN, SOMATROPIN, SOMATROPIN, |
||||
| 630 | 26296593 |
CO |
1 | |
Drug dose omission by device, Device breakage, Product communication issue, Device mechanical issue, |
||||
SOMATROPIN, |
||||
| 631 | 26296604 |
US |
7 | 1 |
Drug dose omission by device, Device information output issue, Device use error, Device breakage, Device mechanical issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 632 | 26296763 |
2 | ||
Sleeve gastrectomy, Device breakage, Complication of device removal, Device dislocation, |
||||
ETONOGESTREL, |
||||
| 633 | 26296767 |
AR |
||
Device breakage, |
||||
SOMATROPIN, |
||||
| 634 | 26296790 |
US |
||
Drug dose omission by device, Device breakage, |
||||
SOMATROPIN, |
||||
| 635 | 26296814 |
KR |
||
Device use error, Device breakage, Device material issue, |
||||
SOMATROPIN, |
||||
| 636 | 26297031 |
US |
15 | 1 |
Device leakage, Device breakage, |
||||
SOMATROPIN, |
||||
| 637 | 26297304 |
GB |
57 | 1 |
Malaise, Cholecystectomy, Device breakage, Medical device site infection, Weight decreased, Bradykinesia, Parkinson^s disease, Post cholecystectomy syndrome, Device colour issue, Device connection issue, Device leakage, Pain, Post procedural complication, Device issue, |
||||
| 638 | 26297753 |
US |
2 | 1 |
Device use error, Device breakage, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 639 | 26297754 |
CO |
2 | |
Device material issue, Device breakage, |
||||
SOMATROPIN, |
||||
| 640 | 26298186 |
US |
1 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 641 | 26287410 |
US |
78 | 2 |
Device breakage, |
||||
RISANKIZUMAB-RZAA, |
||||
| 642 | 26288555 |
US |
2 | |
Surgery, Device breakage, Foreign body in reproductive tract, Complication of device removal, Embedded device, Uterine cervix stenosis, Psychological trauma, Fear, Procedural pain, Emotional distress, Complication associated with device, Pain, Device expulsion, Vaginal infection, Abnormal uterine bleeding, |
||||
COPPER, |
||||
| 643 | 26288665 |
US |
68 | |
Cough, Wrong technique in product usage process, Device breakage, Device difficult to use, Device deposit issue, |
||||
ALBUTEROL SULFATE, ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITSLOPRAM, |
||||
| 644 | 26291346 |
US |
1 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 645 | 26291751 |
US |
||
No adverse event, Syringe issue, Device breakage, |
||||
EPINEPHRINE, ADRENALINUM, |
||||
| 646 | 26282514 |
US |
4 | 1 |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 647 | 26282525 |
US |
56 | |
Device breakage, Device delivery system issue, Off label use, |
||||
LIRAGLUTIDE, LIRAGLUTIDE, LIRAGLUTIDE, |
||||
| 648 | 26284384 |
US |
1 | |
Drug dose omission by device, Device breakage, Expired device used, |
||||
INTERFERON BETA-1B, |
||||
| 649 | 26286139 |
78 | 1 | |
Femur fracture, Fall, Device defective, Poor quality device used, Device breakage, |
||||
MOMETASONE FUROATE, MOMETASONE FUROATE, |
||||
| 650 | 26286195 |
US |
64 | |
Osteoarthritis, Spondylolisthesis, Intervertebral disc protrusion, Intervertebral disc protrusion, Device breakage, Food craving, Product use issue, |
||||
SEMAGLUTIDE, |
||||
| 651 | 26286598 |
US |
10 | 1 |
Device breakage, |
||||
SOMATROPIN, |
||||
| 652 | 26286604 |
US |
41 | 2 |
Device use error, Device breakage, Device issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 653 | 26286616 |
CO |
1 | |
Device breakage, |
||||
SOMATROPIN, |
||||
| 654 | 26286620 |
US |
14 | 2 |
Device breakage, |
||||
SOMATROPIN, |
||||
| 655 | 26287145 |
CA |
79 | 1 |
General physical health deterioration, Device breakage, Subcutaneous abscess, Abscess neck, |
||||
LEVODOPA, LEVODOPA, LEVODOPA, ERGOCALCIFEROL, ATORVASTATIN CALCIUM, ENTACAPONE, FUROSEMIDE, CLONAZEPAM, POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL (3350), POLYETHYLENE GLYCOL 400, INSTALAX POLYETHYLENE GLYCOL 3350, METOPROLOL TARTRATE, METOPROLOL, MAGNESIUM, |
||||
| 656 | 26277230 |
US |
1 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 657 | 26277956 |
US |
||
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 658 | 26278468 |
US |
1 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 659 | 26279931 |
US |
1 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 660 | 26281755 |
US |
||
Device breakage, |
||||
RISPERIDONE, RISPERIDONE, RISPERIDONE, RISPERIDONE, |
||||
| 661 | 26291087 |
|||
Complication of device removal, Complication of device removal, Device breakage, Foreign body in throat, |
||||
LIDOCAINE, LIDOCAINE HYDROCHLORIDE, BURN RELIEF, LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE, LIDOCAINE 4%, LIDOCAINE, MENTHOL, |
||||
| 662 | 26275876 |
US |
1 | |
Circumstance or information capable of leading to medication error, Circumstance or information capable of leading to device use error, Product use issue, Device breakage, |
||||
SOMATROPIN, |
||||
| 663 | 26276012 |
US |
52 | 2 |
Diabetes mellitus inadequate control, Device breakage, Drug ineffective, |
||||
INSULIN GLARGINE, INSULIN GLARGINE, |
||||
| 664 | 26276257 |
AU |
81 | 1 |
Hip surgery, Dementia, Akinesia, Stoma site hypergranulation, Micturition urgency, Musculoskeletal stiffness, Stoma site haemorrhage, Hallucination, Cognitive disorder, Device breakage, Device issue, |
||||
| 665 | 26275081 |
US |
2 | |
Dyspnoea, Device breakage, Product information content complaint, |
||||
TREPROSTINIL, TREPROSTINIL, FUROSEMIDE, ALBUTEROL SULFATE, EMPAGLIFLOZIN, LOSARTAN POTASSIUM, LOSARTAN, ERGOCALCIFEROL, UMECLIDINIUM, ATORVASTATIN CALCIUM, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, CALCIUM, FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE, METFORMIN HYDROCHLORIDE, METFORMIN, METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, METFORMIN HYDROCHLORIDE TABLET, METFORMIN HYDROCHLORIDE TABLETS, |
||||
| 666 | 26275089 |
US |
2 | |
Device use issue, Device breakage, |
||||
SOMATROPIN, |
||||
| 667 | 26275136 |
US |
||
Device use issue, Device breakage, |
||||
SOMATROPIN, |
||||
| 668 | 26270819 |
US |
||
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 669 | 26271050 |
US |
28 | 2 |
Surgery, Device breakage, Foreign body in reproductive tract, Complication of device removal, Embedded device, Complication of device insertion, Dysmenorrhoea, Abnormal uterine bleeding, Dyspareunia, Pelvic pain, Intentional device use issue, Off label use, |
||||
COPPER, |
||||
| 670 | 26271051 |
US |
2 | |
Surgery, Device breakage, Foreign body in reproductive tract, Complication of device removal, Embedded device, Device issue, Device material issue, Emotional distress, Procedural pain, Procedural haemorrhage, Anxiety, Headache, Fatigue, Heavy menstrual bleeding, |
||||
COPPER, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE, SUMATRIPTAN, SUMATRIPTAN SUCCINATE, |
||||
| 671 | 26271246 |
US |
2 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 672 | 26271792 |
US |
||
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 673 | 26271805 |
US |
13 | 1 |
Drug dose omission by device, Device breakage, |
||||
SOMATROPIN, |
||||
| 674 | 26272191 |
US |
14 | 1 |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 675 | 26272722 |
US |
2 | |
Device breakage, Complication of device insertion, |
||||
LEVONORGESTREL, |
||||
| 676 | 26273579 |
US |
1 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 677 | 26273594 |
US |
1 | |
Incorrect dose administered by device, Device breakage, |
||||
SOMATROPIN, |
||||
| 678 | 26273643 |
US |
2 | |
Complication of device removal, Device breakage, Uterine perforation, |
||||
LEVONORGESTREL, |
||||
| 679 | 26274306 |
US |
2 | |
Inappropriate schedule of product administration, Device breakage, |
||||
FLUTICASONE PROPIONATE AND SALMETEROL, FLUTICASONE PROPIONATE AND SALMETEROL, FLUTICASONE PROPIONATE AND SALMETEROL, FLUTICASONE PROPIONATE AND SALMETEROL, |
||||
| 680 | 26274326 |
US |
2 | |
Product use issue, Device breakage, Device malfunction, Device mechanical issue, |
||||
FLUTICASONE PROPIONATE AND SALMETEROL, FLUTICASONE PROPIONATE AND SALMETEROL, FLUTICASONE PROPIONATE AND SALMETEROL, FLUTICASONE PROPIONATE AND SALMETEROL, FLUTICASONE PROPIONATE AND SALMETEROL, FLUTICASONE PROPIONATE AND SALMETEROL, FLUTICASONE PROPIONATE AND SALMETEROL, FLUTICASONE PROPIONATE AND SALMETEROL, |
||||
| 681 | 26274394 |
US |
10 | 2 |
Device use error, Device breakage, Device leakage, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 682 | 26267686 |
US |
31 | 2 |
Surgery, Device breakage, Foreign body in reproductive tract, Complication of device removal, Procedural haemorrhage, Pain, Heavy menstrual bleeding, Abnormal uterine bleeding, Pelvic pain, Device dislocation, |
||||
COPPER, AMITRIPTYLINE HYDROCHLORIDE, CLONAZEPAM, MELOXICAM, FLUOXETINE HYDROCHLORIDE, RISPERIDONE, |
||||
| 683 | 26268547 |
US |
||
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 684 | 26269241 |
MX |
46 | 2 |
Blood glucose increased, Device failure, Device loosening, Device breakage, Drug dose omission by device, |
||||
INSULIN DEGLUDEC AND LIRAGLUTIDE, INSULIN DEGLUDEC AND LIRAGLUTIDE, DAPAGLIFLOZIN, |
||||
| 685 | 26269320 |
US |
1 | |
Off label use, Intentional product use issue, Device breakage, |
||||
SOMATROPIN, |
||||
| 686 | 26269351 |
US |
||
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 687 | 26269675 |
US |
||
Circumstance or information capable of leading to medication error, Device breakage, |
||||
GLATIRAMER ACETATE, GLATIRAMER ACETATE, |
||||
| 688 | 26262797 |
US |
2 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 689 | 26263047 |
US |
45 | 2 |
Surgery, Device breakage, Foreign body in reproductive tract, Complication of device removal, Embedded device, Off label use, Complication of device insertion, Emotional distress, Vulvovaginal pain, Fear, Suprapubic pain, Procedural pain, Pain, Abnormal uterine bleeding, Abdominal pain, Menstruation irregular, Amenorrhoea, Device dislocation, |
||||
COPPER, |
||||
| 690 | 26263048 |
US |
36 | 2 |
Surgery, Device breakage, Foreign body in urogenital tract, Complication of device removal, Emotional distress, Intentional device use issue, Off label use, |
||||
COPPER, |
||||
| 691 | 26263049 |
US |
2 | |
Surgery, Device breakage, Foreign body in reproductive tract, Complication of device removal, Laryngeal ulceration, Dysphonia, Post procedural haemorrhage, Anxiety, Emotional distress, Procedural pain, Muscle spasms, Pain, Device use issue, Off label use, Endometritis, Heavy menstrual bleeding, Abnormal uterine bleeding, Menstruation irregular, Intermenstrual bleeding, |
||||
COPPER, MOMETASONE FUROATE, |
||||
| 692 | 26263050 |
US |
2 | |
Surgery, Device breakage, Foreign body in reproductive tract, Complication of device removal, Emotional distress, Pain, Nausea, |
||||
COPPER, LEVOTHYROXINE SODIUM, |
||||
| 693 | 26263092 |
US |
1 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 694 | 26263122 |
US |
1 | |
Circumstance or information capable of leading to device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 695 | 26264585 |
US |
2 | |
Circumstance or information capable of leading to medication error, Device breakage, |
||||
SOMATROPIN, |
||||
| 696 | 26264676 |
CO |
||
Device breakage, Device issue, |
||||
SOMATROPIN, |
||||
| 697 | 26264678 |
KR |
||
Device use error, Device breakage, Device material issue, |
||||
SOMATROPIN, |
||||
| 698 | 26265002 |
US |
1 | |
Device use error, Device breakage, |
||||
SOMATROPIN, |
||||
| 699 | 26265161 |
US |
12 | 2 |
Product prescribing error, Drug dose omission by device, Device mechanical issue, Device breakage, |
||||
SOMATROPIN, SOMATROPIN, SOMATROPIN, |
||||
| 700 | 26265543 |
US |
10 | 2 |
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
