Drug:
Reaction: DEVICE ISSUE
20250101 - 20251231
No. 701 - 800
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 701 | 25004122 |
US |
11 | 1 |
Drug dose omission by device, Device breakage, Device issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 702 | 25004764 |
US |
2 | |
Device issue, Product dose omission issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 703 | 25005433 |
SA |
||
Device issue, Product dose omission issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 704 | 25005636 |
FR |
1 | |
Product dose omission issue, Device issue, |
||||
SOMATROPIN, |
||||
| 705 | 25006224 |
US |
2 | |
Device issue, Product dose omission issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 706 | 25006260 |
CA |
49 | 2 |
Device issue, Incorrect dose administered, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 707 | 25006430 |
US |
2 | |
Device issue, Product dose omission issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 708 | 25001294 |
US |
79 | 2 |
Device issue, Incorrect dose administered by device, Device safety feature issue, |
||||
ABATACEPT, |
||||
| 709 | 25001377 |
US |
2 | |
Injection site pain, Device issue, Skin injury, Incorrect dose administered, Device leakage, Product dose omission issue, |
||||
SECUKINUMAB, |
||||
| 710 | 25001479 |
IT |
10 | 2 |
Drug dose omission by device, Device mechanical issue, Device issue, |
||||
SOMATROPIN, |
||||
| 711 | 25001518 |
US |
2 | |
Product quality issue, Device issue, |
||||
ESKETAMINE HYDROCHLORIDE, |
||||
| 712 | 24997312 |
US |
2 | |
Vascular device occlusion, Device use error, Device infusion issue, Device issue, |
||||
TREPROSTINIL, TREPROSTINIL, ACETAMINOPHEN, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, ZOLPIDEM TARTRATE, PANTOPRAZOLE SODIUM, PANTOPRAZOLE, PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE, PANTOPRAZOLE SODIUM INJECTION, ALBUTEROL SULFATE, SILDENAFIL CITRATE, SILDENAFIL, SILDENAFIL POWDER,, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATED, APIXABAN, AMBRISENTAN, BUMETANIDE, SPIRONOLACTONE, |
||||
| 713 | 24997408 |
US |
2 | |
Stoma complication, Device leakage, Device issue, |
||||
| 714 | 24997968 |
US |
18 | 1 |
Injection site haemorrhage, Device issue, |
||||
DUPILUMAB, |
||||
| 715 | 24998113 |
US |
77 | 1 |
Blood glucose decreased, Device issue, |
||||
INSULIN GLARGINE, INSULIN GLARGINE, INSULIN GLARGINE, |
||||
| 716 | 24998294 |
US |
64 | 1 |
Injection site pain, Injection site swelling, Device issue, Formication, Pruritus, Therapeutic response shortened, |
||||
DUPILUMAB, |
||||
| 717 | 24998489 |
US |
80 | 1 |
Blood glucose increased, Device issue, Wrong technique in device usage process, Intentional product use issue, |
||||
INSULIN GLARGINE, INSULIN GLARGINE, |
||||
| 718 | 24998601 |
US |
48 | 2 |
Dyspnoea, Pain, Infusion site pain, Infusion site erythema, Infusion site urticaria, Infusion site reaction, Device issue, Device issue, Device issue, Device occlusion, Device dislocation, Therapy partial responder, |
||||
TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, ACETAMINOPHEN, KETAMINE HYDROCHLORIDE, SILDENAFIL CITRATE, SILDENAFIL, SILDENAFIL POWDER,, CLONIDINE, KETOPROFEN, LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE ANHYDROUS, GABAPENTIN, |
||||
| 719 | 24998699 |
US |
||
Injection site pain, Injection site swelling, Device issue, |
||||
DUPILUMAB, |
||||
| 720 | 24998872 |
US |
65 | 1 |
Blood glucose increased, Device issue, |
||||
INSULIN LISPRO, |
||||
| 721 | 24999174 |
US |
72 | 2 |
Blood glucose increased, Device issue, Wrong technique in device usage process, Intentional product misuse, |
||||
INSULIN GLARGINE, |
||||
| 722 | 24999195 |
US |
43 | 2 |
Blood glucose increased, Drug dose omission by device, Device issue, Wrong technique in device usage process, Off label use, |
||||
INSULIN GLARGINE, |
||||
| 723 | 24999536 |
US |
70 | 2 |
Injection site pain, Device issue, Cough, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 724 | 24999590 |
US |
66 | 2 |
Blood glucose increased, Product dose omission issue, Device issue, |
||||
INSULIN GLARGINE, |
||||
| 725 | 25000857 |
US |
78 | 2 |
Blood glucose increased, Device issue, |
||||
INSULIN GLARGINE, |
||||
| 726 | 25001083 |
US |
8 | 2 |
Product knowledge deficit, Device issue, Device defective, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 727 | 24992662 |
US |
42 | 2 |
Device issue, Weight decreased, Nasopharyngitis, Asthma, |
||||
RISANKIZUMAB-RZAA, |
||||
| 728 | 24993655 |
US |
1 | |
Device delivery system issue, Incorrect dose administered by device, Device issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 729 | 24993826 |
US |
2 | |
Device issue, Accidental exposure to product, Product dose omission issue, |
||||
SECUKINUMAB, |
||||
| 730 | 24993911 |
US |
62 | 1 |
Intestinal obstruction, Scar, Device issue, Injection site bruising, |
||||
ADALIMUMAB, |
||||
| 731 | 24993965 |
US |
8 | 1 |
Injection site pain, Device leakage, Device issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 732 | 24993977 |
US |
||
Device issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 733 | 24994036 |
JP |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 734 | 24994324 |
TW |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 735 | 24994536 |
US |
2 | |
Pregnancy with implant contraceptive, Unintended pregnancy, Implant site scar, Complication of device removal, Device issue, Device deployment issue, Complication associated with device, Incorrect product administration duration, Product use issue, |
||||
ETONOGESTREL, |
||||
| 736 | 24994984 |
US |
34 | 2 |
Crohn^s disease, Device issue, Device malfunction, Product dose omission issue, |
||||
USTEKINUMAB, USTEKINUMAB, LISDEXAMFETAMINE DIMESYLATE, ALPRAZOLAM, |
||||
| 737 | 24996425 |
US |
||
Drug dose omission by device, Poor quality device used, Device material issue, Device issue, |
||||
SOMATROPIN, |
||||
| 738 | 24996715 |
US |
35 | 2 |
Injection site vesicles, Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 739 | 24996897 |
US |
80 | 1 |
Fall, Device issue, Hallucination, |
||||
FOSCARBIDOPA/FOSLEVODOPA, FOSCARBIDOPA/FOSLEVODOPA, |
||||
| 740 | 24997272 |
US |
2 | |
Circumstance or information capable of leading to medication error, Device issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 741 | 24997284 |
US |
11 | 2 |
Injection site pain, Device issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 742 | 24997311 |
US |
66 | 2 |
Insomnia, Drug hypersensitivity, Device issue, Device wireless communication issue, |
||||
TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE, CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN, SULFAMETHOXAZOLE AND TRIMETHOPRIM, CEPHALEXIN, OXYBUTYNIN CHLORIDE, FUROSEMIDE, TIOTROPIUM BROMIDE, APIXABAN, FOLIC ACID, LEVOTHYROXINE, SODIUM CHLORIDE, SODIUM CHLORIDE INJECTION, SODIUM CHLORIDE TABLET, NORMAL SALT TABLETS, ALBUTEROL SULFATE, CYANOCOBALAMIN, ERGOCALCIFEROL, AMBRISENTAN, DIPHENHYDRAMINE HYDROCHLORIDE, OXYGEN, 0XYGEN, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, CETIRIZINE HCL, CETIRIZINE, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, |
||||
| 743 | 24988168 |
US |
64 | 2 |
Device issue, Underdose, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 744 | 24989353 |
US |
2 | |
Injection site bruising, Device issue, |
||||
ADALIMUMAB, |
||||
| 745 | 24989764 |
US |
30 | 2 |
Surgery, Complication associated with device, Complication of device removal, Device issue, Wrong technique in product usage process, |
||||
ETONOGESTREL, |
||||
| 746 | 24989913 |
JP |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 747 | 24990144 |
DE |
||
Device issue, |
||||
AFLIBERCEPT, |
||||
| 748 | 24990352 |
US |
55 | 1 |
Fistula, Wrong technique in product usage process, Fatigue, Cough, Device issue, |
||||
RISANKIZUMAB-RZAA, TESTOSTERONE, TESTOSTERONE,, |
||||
| 749 | 24990556 |
US |
37 | 2 |
Device issue, Injection site haemorrhage, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 750 | 24990636 |
FR |
37 | 2 |
Device issue, Product dose omission issue, |
||||
GUSELKUMAB, GUSELKUMAB, |
||||
| 751 | 24990652 |
US |
2 | |
Needle issue, Device issue, Injury associated with device, Accidental exposure to product, Incorrect dose administered by device, Off label use, |
||||
CANAKINUMAB, CANAKINUMAB, CANAKINUMAB, CANAKINUMAB, |
||||
| 752 | 24990991 |
US |
57 | |
Injection site bruising, Wrong technique in device usage process, Product dose omission issue, Incorrect dose administered by device, Device leakage, Device issue, Device use issue, |
||||
EXENATIDE, |
||||
| 753 | 24991051 |
DE |
2 | |
Fall, Device issue, Device dislocation, |
||||
| 754 | 24991109 |
US |
||
Device use issue, Incorrect dose administered by device, Device issue, Device delivery system issue, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 755 | 24991514 |
US |
63 | 1 |
Device issue, Off label use, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 756 | 24991540 |
US |
36 | 1 |
Product dose omission issue, Device issue, Device leakage, |
||||
PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE, |
||||
| 757 | 24992303 |
US |
14 | |
Circumstance or information capable of leading to medication error, Device leakage, Device issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 758 | 24992489 |
GB |
2 | |
Lower respiratory tract infection, Surgery, Rheumatoid arthritis, Chronic obstructive pulmonary disease, Device issue, |
||||
GOLIMUMAB, |
||||
| 759 | 24992490 |
US |
86 | 2 |
Stress, Tremor, Hypoaesthesia, Hordeolum, Device issue, |
||||
RISANKIZUMAB-RZAA, ERGOCALCIFEROL, CYCLOSPORINE, |
||||
| 760 | 24992538 |
US |
1 | |
Drug dose omission by device, Device issue, Product label issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 761 | 24983277 |
US |
14 | 1 |
Injection site discharge, Incorrect dose administered, Accidental exposure to product, Device issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 762 | 24983780 |
US |
43 | 2 |
Injury associated with device, Device issue, Product dose omission issue, Wrong technique in product usage process, Off label use, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 763 | 24983875 |
US |
52 | 1 |
Chest pain, Device leakage, Headache, Nausea, Decreased appetite, Diarrhoea, Device alarm issue, Device issue, Device malfunction, Vomiting, Asthenia, Product use issue, |
||||
TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, RIOCIGUAT, TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE OINTMENT USP, 0.05%, |
||||
| 764 | 24984032 |
CA |
72 | 1 |
Ear canal stenosis, Bell^s palsy, Ear swelling, Jaw disorder, Lip swelling, Neoplasm malignant, Infusion site swelling, Device issue, |
||||
HUMAN IMMUNOGLOBULIN G, HUMAN IMMUNOGLOBULIN G, |
||||
| 765 | 24984248 |
US |
||
Accidental exposure to product, Device issue, |
||||
ONABOTULINUMTOXINA, |
||||
| 766 | 24984252 |
US |
21 | 2 |
Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 767 | 24984405 |
CA |
75 | 2 |
Device infusion issue, Device issue, Frequent bowel movements, Incorrect product administration duration, Infection, Infusion site pain, Mastitis, Oral herpes, Rib fracture, Wrist fracture, Off label use, |
||||
HUMAN IMMUNOGLOBULIN G, HUMAN IMMUNOGLOBULIN G, HUMAN IMMUNOGLOBULIN G, BRIMONIDINE TARTRATE, CALCIUM, CYANOCOBALAMIN, DICYCLOMINE HYDROCHLORIDE, ALENDRONATE SODIUM, IBUPROFEN, IBUPROFEN CAPSULES 200 MG, IBUPROFEN TABLETS USP, 200MG, IBUPROFEN ORAL, IBUPROFEN 200MG, IBUPFROFEN, IBUPROFEN TABLET, FILM-COATED, IBUPROFEN 200 MG, IBUPROFEN CAPSULE, MAGNESIUM, PANTOPRAZOLE, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, ESTRADIOL, ERGOCALCIFEROL, ZOLMITRIPTAN, |
||||
| 768 | 24984533 |
FR |
40 | 2 |
Device issue, Product dose omission issue, |
||||
GOLIMUMAB, |
||||
| 769 | 24984614 |
US |
||
Device issue, |
||||
| 770 | 24984676 |
US |
57 | 2 |
Injection site bruising, Injection site pain, Injection site reaction, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, PANTOPRAZOLE, TRIAMTERENE CAPSULES, TRIAMTERENE, ROSUVASTATIN, SEMAGLUTIDE, PROPAFENONE, LEVOTHYROXINE, |
||||
| 771 | 24984907 |
US |
42 | 1 |
Device issue, Incorrect dose administered, No adverse event, Accidental exposure to product, Needle issue, Syringe issue, Product administration error, |
||||
OMALIZUMAB, OMALIZUMAB, |
||||
| 772 | 24985052 |
BR |
33 | 2 |
Vaginal haemorrhage, Device issue, Device deployment issue, Complication associated with device, Complication of device removal, |
||||
ETONOGESTREL, |
||||
| 773 | 24985112 |
US |
13 | 2 |
Device dispensing error, Incorrect dose administered by device, Device issue, |
||||
SECUKINUMAB, |
||||
| 774 | 24985122 |
US |
17 | 2 |
Product dose omission issue, Syringe issue, Off label use, Device issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 775 | 24985166 |
FR |
||
Device issue, Product dose omission issue, |
||||
GOLIMUMAB, |
||||
| 776 | 24985430 |
US |
30 | 2 |
Product dose omission issue, Device issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 777 | 24985582 |
US |
78 | 2 |
Device issue, Device adhesion issue, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, |
||||
| 778 | 24985803 |
US |
2 | |
Needle issue, Product packaging quantity issue, Inadvertent injection air bubble, Incorrect dose administered by device, Device malfunction, Device issue, |
||||
SECUKINUMAB, |
||||
| 779 | 24985956 |
JP |
||
Device issue, Device material issue, |
||||
| 780 | 24986230 |
CO |
1 | |
Device mechanical issue, Device issue, Wrong technique in device usage process, |
||||
SOMATROPIN, |
||||
| 781 | 24986520 |
JP |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 782 | 24986782 |
US |
2 | |
Device difficult to use, Product packaging issue, Device issue, Product design issue, |
||||
ESTRADIOL, ESTRADIOL GEL 0.1%, ESTRADIOL TRANSDERMAL, ESTRADIOL,, |
||||
| 783 | 24987563 |
AU |
||
Device issue, |
||||
DARUNAVIR, |
||||
| 784 | 24987651 |
US |
2 | |
Injection site pain, Device issue, Drug hypersensitivity, Drug specific antibody present, |
||||
ADALIMUMAB, |
||||
| 785 | 24987725 |
US |
2 | |
Inappropriate schedule of product administration, Accidental exposure to product, Device issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 786 | 24987765 |
US |
73 | 2 |
Diarrhoea, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, ERGOCALCIFEROL, RUXOLITINIB, LOSARTAN, AZITHROMYCIN, AZITHROMYCIN MONOHYDRATE, AZITHROMYCIN DIHYDRATE, KETOCONAZOLE, KETOCONAZOLE FOAM, KETOCONAZOLE CREAM, 2%, ACYCLOVIR, PREDNISONE, BELUMOSUDIL, BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, METOPROLOL SUCCINATE, METOPROLOL SUCCINATE ER TABLETS, TERIPARATIDE, LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE, FOLIC ACID, URSODIOL, URSOSIOL, ZINC, ZINC GLUCONATE, ZINC CHLORIDE, APIXABAN, MINOXIDIL, OIL, LIFITEGRAST, OIL, BIOTIN, HAIR, MONTELUKAST, |
||||
| 787 | 24987901 |
US |
1 | |
Incorrect dose administered by device, Device issue, Drug dose omission by device, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 788 | 24987995 |
CH |
61 | 1 |
Hip fracture, Off label use, Device occlusion, Device issue, |
||||
| 789 | 24978800 |
US |
49 | 2 |
Device issue, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, |
||||
| 790 | 24979035 |
FR |
2 | |
Product dose omission issue, Device issue, |
||||
GOLIMUMAB, |
||||
| 791 | 24979049 |
US |
75 | 2 |
Device issue, Product dose omission issue, Arthritis, Off label use, Nausea, |
||||
GOLIMUMAB, |
||||
| 792 | 24979214 |
US |
2 | |
Device issue, Product dose omission issue, |
||||
FLUTICASONE PROPIONATE, |
||||
| 793 | 24979910 |
US |
||
Device issue, |
||||
| 794 | 24979912 |
US |
||
Device issue, |
||||
| 795 | 24979913 |
US |
||
Device issue, |
||||
| 796 | 24979914 |
US |
||
Device issue, |
||||
| 797 | 24980080 |
US |
||
Device issue, Dyspnoea, Drug ineffective, Visual impairment, Wrong technique in device usage process, Chronic obstructive pulmonary disease, Drug dose omission by device, Intentional product use issue, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 798 | 24980414 |
US |
2 | |
Pregnancy with implant contraceptive, Unintended pregnancy, Device issue, Device deployment issue, Complication associated with device, Complication of device removal, Incorrect product administration duration, |
||||
ETONOGESTREL, |
||||
| 799 | 24980496 |
VE |
29 | 2 |
Pregnancy with contraceptive device, Haemorrhage in pregnancy, Foetal death, Amniorrhexis, Drug ineffective, Device issue, |
||||
LEVONORGESTREL, |
||||
| 800 | 24980648 |
US |
32 | 2 |
Embedded device, Device issue, |
||||
LEVONORGESTREL, |
||||
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
2025-04-28