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Drug Search by Year (Detail)

Side effect search by year (detail)

Drug:

Reaction: DEVICE MALFUNCTION

20260101 - 20261231

No. 601 - 700

Next page: 8 next page>>
No.
safetyreportid
occurcountry
patientonsetage
patientsex 1:M 2:F
Adverse reaction
Drug (openfda.generic_name, medicinalproduct)
601
26852839
US
61
Device malfunction, Drug dose omission by device,
ADALIMUMAB-AATY, ADALIMUMAB-AATY, HYDROCHLOROTHIAZIDE,
602
26852908
US
74
Device malfunction, Drug dose omission by device, Device issue,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP,
603
26852912
US
68
Exposure via skin contact, Accidental exposure to product, Device malfunction,
ADALIMUMAB-AATY, ADALIMUMAB-AATY,
604
26852922
US
73
Device malfunction, Incorrect dose administered by device,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP,
605
26852933
US
43
Device malfunction, Incorrect dose administered by device,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, HYDROXYCHLOROQUINE, METHOTREXATE, METHOTREXATE SODIUM,
606
26852938
US
30
Device malfunction, Needle issue, Drug dose omission by device, Suspected off label use,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP,
607
26852962
US
54
Bronchitis, Urinary tract infection, Device malfunction, Drug dose omission by device,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP,
608
26852979
US
74 2
Device malfunction, Accidental exposure to product, Product dose omission issue, Injection site pain, Slow speech,
GUSELKUMAB,
609
26852981
US
26
Device malfunction, Product dose omission issue,
ADALIMUMAB-AATY, ADALIMUMAB-AATY,
610
26853007
US
64
Incorrect dose administered, Device malfunction,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP,
611
26853616
US
53 2
Contusion, Device malfunction,
612
26853704
US
2
Blood glucose increased, Device malfunction,
INSULIN ASPART,
613
26853783
US
46 1
Device mechanical issue, No adverse event, Device malfunction,
LIRAGLUTIDE,
614
26853792
US
33
Injection site indentation, Device malfunction, Device leakage,
615
26853854
US
2
Device malfunction, No adverse event,
LIRAGLUTIDE,
616
26853887
US
Incorrect dose administered by device, Visual impairment, Glycosylated haemoglobin decreased, Device malfunction,
ORAL SEMAGLUTIDE,
617
26853890
US
Device malfunction, Product dose omission issue,
NEMOLIZUMAB-ILTO,
618
26853898
US
70 1
Nausea, Constipation, Dyspepsia, Muscle spasms, Product dose omission issue, Diarrhoea, Device malfunction, Device leakage,
EVOLOCUMAB,
619
26854150
US
60 2
Device malfunction, No adverse event, Drug dose omission by device, Device defective, Incorrect dose administered by device, Device delivery system issue,
LIRAGLUTIDE, LISINOPRIL, LOVASTATIN, EMPAGLIFLOZIN, AMLODIPINE,
620
26854196
US
34 2
Off label use, Intercepted product administration error, Wrong technique in product usage process, Device malfunction,
LEUPROLIDE ACETATE, LEUPROLIDE ACETATE, LEUPROLIDE ACETATE,
621
26854234
US
Visual impairment, Device malfunction,
622
26854340
BR
2
Pulmonary fibrosis, Pneumonia, Pneumonia, Lung disorder, Lung disorder, Chronic obstructive pulmonary disease, Fatigue, Off label use, Product ineffective for unapproved use, Device malfunction, Product ineffective for unapproved use, Device malfunction, Product ineffective for unapproved use, Device malfunction, Product ineffective for unapproved use, Device malfunction, Product ineffective for unapproved use, Device malfunction,
BECLOMETHASONE DIPROPIONATE/FORMOTEROL FUMARATE/GLYCOPYRROLATE, BECLOMETHASONE DIPROPIONATE/FORMOTEROL FUMARATE/GLYCOPYRROLATE, BECLOMETHASONE DIPROPIONATE/FORMOTEROL FUMARATE/GLYCOPYRROLATE, BECLOMETHASONE DIPROPIONATE/FORMOTEROL FUMARATE/GLYCOPYRROLATE, BECLOMETHASONE DIPROPIONATE/FORMOTEROL FUMARATE/GLYCOPYRROLATE, BECLOMETHASONE DIPROPIONATE/FORMOTEROL FUMARATE/GLYCOPYRROLATE, BECLOMETHASONE DIPROPIONATE/FORMOTEROL FUMARATE/GLYCOPYRROLATE, DESVENLAFAXINE SUCCINATE, PREGABALIN, ZOLPIDEM TARTRATE, FLUOXETINE HYDROCHLORIDE, FLUOXETINE, ERGOCALCIFEROL, MAGNESIUM, ESOMEPRAZOLE MAGNESIUM,
623
26854369
US
66
Blood glucose fluctuation, Device malfunction,
ORAL SEMAGLUTIDE,
624
26854493
US
43 2
Device delivery system issue, No adverse event, Device malfunction, Device mechanical issue, Drug dose omission by device,
LIRAGLUTIDE,
625
26854551
US
Device malfunction, No adverse event, Device malfunction,
PEGFILGRASTIM-CBQV,
626
26854728
US
50 1
Wrong technique in device usage process, Product prescribing issue, Device delivery system issue, Device malfunction,
BUDESONIDE AND FORMOTEROL FUMARATE,
627
26854783
US
42
Incorrect dose administered, Device malfunction,
NEMOLIZUMAB-ILTO,
628
26854796
US
63 2
Rhinovirus infection, Wrong technique in device usage process, Device malfunction,
OMALIZUMAB,
629
26855346
US
75
Incorrect dose administered by device, Device malfunction, Wrong technique in product usage process, No adverse event,
ALBUTEROL SULFATE,
630
26855363
US
47
Device malfunction, Device delivery system issue, Exposure via skin contact, Accidental exposure to product, Drug dose omission by device,
ADALIMUMAB-AATY, ADALIMUMAB-AATY, ADALIMUMAB-AATY, DULOXETINE HYDROCHLORIDE, BACLOFEN, PREGABALIN, METHOTREXATE, METHOTREXATE SODIUM, FOLIC ACID, SULFASALAZINE,
631
26855400
US
72
Device malfunction, Exposure via skin contact, Accidental exposure to product, Drug dose omission by device, Suspected off label use,
ADALIMUMAB-AATY, ADALIMUMAB-AATY, ADALIMUMAB-AATY, ADALIMUMAB-AATY, COLESTIPOL HYDROCHLORIDE,
632
26855410
US
Device malfunction, Wrong technique in product usage process,
ADALIMUMAB-AATY, ADALIMUMAB-AATY,
633
26855440
US
65
Device malfunction, Drug dose omission by device,
ADALIMUMAB-AATY, ADALIMUMAB-AATY,
634
26855962
US
Product dose omission issue, Device malfunction,
BIMEKIZUMAB,
635
26856066
US
79 2
Device malfunction, Product storage issue,
ABATACEPT, AMLODIPINE, IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE, BACLOFEN, DAPAGLIFLOZIN, FLUTICASONE PROPIONATE, ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL, POLYETHYLENE GLYCOL 3350, SPIRONOLACTONE, BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, ERGOCALCIFEROL, WARFARIN, LEVALBUTEROL TARTRATE, CETIRIZINE HYDROCHLORIDE,
636
26856192
US
2
Inappropriate schedule of product administration, Device malfunction,
FLUTICASONE PROPIONATE AND SALMETEROL, FLUTICASONE PROPIONATE AND SALMETEROL, FLUTICASONE PROPIONATE AND SALMETEROL, FLUTICASONE PROPIONATE AND SALMETEROL,
637
26856396
US
30 1
Injection site discomfort, Product use in unapproved indication, Device malfunction,
TRALOKINUMAB-LDRM,
638
26857091
US
70
Incorrect dose administered, Device malfunction,
NEMOLIZUMAB-ILTO, TIRZEPATIDE,
639
26857098
US
49
Device malfunction, Product dose omission issue,
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO,
640
26857158
US
42 2
Needle issue, Device malfunction, Device leakage, Accidental exposure to product, Drug dose omission by device,
SECUKINUMAB,
641
26857265
US
1
Furuncle, Needle issue, Device leakage, Device malfunction,
SECUKINUMAB, LORAZEPAM,
642
26847197
US
37
Product dose omission issue, Device malfunction,
NEMOLIZUMAB-ILTO,
643
26847221
US
66
Product dose omission issue, Device malfunction,
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO,
644
26847267
BR
2
Ill-defined disorder, Amyotrophic lateral sclerosis, Wrong technique in device usage process, Wrong technique in device usage process, Device malfunction, Device physical property issue,
BECLOMETHASONE DIPROPIONATE/FORMOTEROL FUMARATE/GLYCOPYRROLATE, RILUZOLE, ARIPIPRAZOLE ORALLY DISINTEGRATING, ARIPIPRAZOLE, ARIPIPRAZOLE ORAL,
645
26847353
US
46 1
Skin injury, Device malfunction, Product quality issue,
ORAL SEMAGLUTIDE,
646
26847815
US
44 1
Intentional overdose, Self-medication, Device deployment issue, Device malfunction, Product dose omission issue, Wrong technique in product usage process,
GUSELKUMAB,
647
26847889
US
2
Incorrect dose administered by product, Device malfunction,
INSULIN DEGLUDEC,
648
26848116
US
78 1
Weight increased, Device failure, Product dose omission issue, Device malfunction, Device issue,
ORAL SEMAGLUTIDE,
649
26848276
US
Product dose omission issue, Device malfunction,
NEMOLIZUMAB-ILTO,
650
26848334
US
Device malfunction, Incorrect dose administered,
NEMOLIZUMAB-ILTO,
651
26848369
US
42
Dermatitis atopic, Device malfunction, Product dose omission issue, Off label use, Intentional underdose,
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO,
652
26848812
US
76 2
Rash, Pruritus, Device malfunction,
TRALOKINUMAB-LDRM, TRALOKINUMAB-LDRM,
653
26849212
US
2
Incorrect dose administered, Device malfunction,
BELIMUMAB,
654
26849296
US
60
Product dose omission issue, Device malfunction,
NEMOLIZUMAB-ILTO,
655
26849597
US
Device malfunction, Product dose omission issue,
NEMOLIZUMAB-ILTO,
656
26849842
US
2
Device malfunction, Injection site pain, Device leakage,
SECUKINUMAB,
657
26849975
US
71 2
Injection site haemorrhage, Device malfunction,
TRALOKINUMAB-LDRM,
658
26850000
CN
Wrong technique in product usage process performed in error, Product delivery mechanism issue, Device malfunction,
659
26850012
US
76 1
Device malfunction, Device delivery system issue, Product quality issue,
BUDESONIDE AND FORMOTEROL FUMARATE,
660
26850016
US
Product dose omission issue, Device malfunction,
NEMOLIZUMAB-ILTO,
661
26850199
US
1
Device malfunction, Wrong technique in device usage process, Product leakage,
GUSELKUMAB,
662
26850406
US
Device malfunction, Product leakage, Product dose omission issue,
GUSELKUMAB, GUSELKUMAB,
663
26851395
US
Device malfunction,
GUSELKUMAB,
664
26851924
US
2
Injection site indentation, Device malfunction, Drug dose omission by device,
665
26851929
US
69 2
Drug dose omission by device, Device malfunction, Device leakage,
666
26856679
1
Vascular device occlusion, Device malfunction,
MACITENTAN, EPOPROSTENOL,
667
26856830
1
Complication associated with device, Device malfunction, Device occlusion,
TADALAFIL, EPOPROSTENOL,
668
26845973
US
Device malfunction, No adverse event,
ENOXAPARIN SODIUM,
669
26844950
US
78
Device malfunction, Accidental exposure to product, Exposure via skin contact,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, METHOTREXATE, METHOTREXATE SODIUM,
670
26844954
US
75
Device malfunction, Drug dose omission by device,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP,
671
26844967
US
76
Device malfunction, Off label use, Inappropriate schedule of product administration,
ADALIMUMAB-AATY, ADALIMUMAB-AATY,
672
26844970
US
Product leakage, Device malfunction, Suspected off label use,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP,
673
26845021
US
77
Device malfunction, Drug dose omission by device, Accidental exposure to product, Exposure via skin contact,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP,
674
26845033
US
39
Device malfunction, Accidental exposure to product, Exposure via skin contact,
ADALIMUMAB-AATY, ADALIMUMAB-AATY,
675
26845131
US
68
Device malfunction, Incorrect dose administered,
NEMOLIZUMAB-ILTO, ORAL SEMAGLUTIDE,
676
26845162
US
No adverse event, Device malfunction, Device malfunction, No adverse event,
PEGFILGRASTIM-CBQV,
677
26845364
US
Incorrect dose administered by device, Device malfunction,
ESKETAMINE HYDROCHLORIDE,
678
26845594
US
2
No adverse event, Device malfunction, No adverse event, Device malfunction,
PEGFILGRASTIM-CBQV,
679
26845678
US
Device malfunction,
NITRIC OXIDE, NITRIC OXIDE,
680
26839732
US
43
Device malfunction, Injection site pain, Accidental exposure to product, Exposure via skin contact,
ADALIMUMAB-AATY, ADALIMUMAB-AATY,
681
26839754
US
56
Device malfunction, Product dose omission issue,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP,
682
26839774
US
77
Device malfunction, Accidental exposure to product, Exposure via skin contact,
ADALIMUMAB-AATY, ADALIMUMAB-AATY,
683
26839785
US
74
Device malfunction, Drug dose omission by device,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP,
684
26839859
US
36
Device malfunction, Exposure via skin contact, Accidental exposure to product, Wrong technique in product usage process, Drug dose omission by device,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP,
685
26839881
US
72
Device malfunction, Exposure via skin contact, Accidental exposure to product,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP,
686
26839970
US
69
Device malfunction, Drug dose omission by device,
ADALIMUMAB-AATY, ADALIMUMAB-AATY,
687
26839996
US
69
Device malfunction, Drug dose omission by device,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP,
688
26840096
US
44
Device malfunction, Product dose omission issue,
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO,
689
26840114
CN
39
Diabetic foot, Injection site mass, Product quality issue, Device malfunction,
690
26840149
US
38
Device malfunction, Product dose omission issue,
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO,
691
26840228
US
68
Injection site bruising, Device malfunction,
ADALIMUMAB-AATY, ADALIMUMAB-AATY,
692
26840298
US
11
Device malfunction, Accidental exposure to product, Exposure via skin contact,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP,
693
26840323
US
49
Device malfunction, Accidental exposure to product, Exposure via skin contact, Drug dose omission by device,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP,
694
26840401
US
70
Device malfunction, Drug dose omission by device,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP,
695
26840431
US
83
Device malfunction, Drug dose omission by device,
ADALIMUMAB-AATY, ADALIMUMAB-AATY,
696
26840453
US
Device malfunction, Exposure via skin contact, Accidental exposure to product,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP,
697
26840515
US
62
Device malfunction, Incorrect dose administered by device,
ADALIMUMAB-AATY, ADALIMUMAB-AATY,
698
26840690
US
33
Product dose omission issue, Device malfunction,
NEMOLIZUMAB-ILTO,
699
26840791
US
46 2
Condition aggravated, Product dose omission issue, Device malfunction,
ADALIMUMAB-RYVK,
700
26841234
US
71 1
Device infusion issue, Device malfunction, Product dose omission issue, Product dose omission issue, Device infusion issue, Device malfunction,
PEGFILGRASTIM-CBQV, PEGFILGRASTIM-CBQV, PEGFILGRASTIM-CBQV, PEGFILGRASTIM-CBQV, EPINEPHRINE, ADRENALINUM,

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

2026-07-30

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