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Drug Search by Year (Detail)

Side effect search by year (detail)

Drug:

Reaction: DEVICE MALFUNCTION

20260101 - 20261231

No. 701 - 800

Next page: 9 next page>>
No.
safetyreportid
occurcountry
patientonsetage
patientsex 1:M 2:F
Adverse reaction
Drug (openfda.generic_name, medicinalproduct)
701
26841268
US
1
Cough, Diarrhoea, Dyspnoea, Therapy non-responder, Device connection issue, Device malfunction,
TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, TESTOSTERONE, NERANDOMILAST, ROSUVASTATIN CALCIUM, PANTOPRAZOLE SODIUM, PANTOPRAZOLE, PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE, PANTOPRAZOLE SODIUM INJECTION, MELATONIN, DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, PREDNISONE, OXYGEN, 0XYGEN, RIVAROXABAN, CLOPIDOGREL, IPRATROPIUM BROMIDE, METFORMIN HYDROCHLORIDE, METFORMIN, METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, METFORMIN HYDROCHLORIDE TABLET, METFORMIN HYDROCHLORIDE TABLETS, LOSARTAN POTASSIUM, LOSARTAN,
702
26841489
US
Product use complaint, Device malfunction, Product leakage, Pain, Product dose omission issue, Device issue,
GUSELKUMAB,
703
26841996
US
63
Drug delivery system malfunction, Drug dose omission by device, Intentional product use issue, Device malfunction, Product supply issue, Product dose omission issue,
ADALIMUMAB-AATY, ADALIMUMAB-AATY,
704
26842182
US
55
Urinary tract infection, Device malfunction, Exposure via skin contact, Accidental exposure to product, Intentional dose omission,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP,
705
26842259
US
44
Accidental exposure to product, Exposure via skin contact, Device malfunction,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP,
706
26842289
US
2
Cough, Multiple allergies, Inappropriate schedule of product administration, Device delivery system issue, Device malfunction,
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE,
707
26842381
US
74 2
Injection site pain, Device malfunction,
708
26842473
US
53
Device malfunction, Drug dose omission by device,
ADALIMUMAB-AATY, ADALIMUMAB-AATY,
709
26842885
US
Device malfunction, Incorrect dose administered,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP,
710
26842900
US
72
Device malfunction, Exposure via skin contact, Accidental exposure to product, Incorrect dose administered by device,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP,
711
26842918
US
Drug dose omission by device, Device malfunction,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP,
712
26842951
US
67
Device malfunction, Incorrect dose administered,
ADALIMUMAB-AATY, ADALIMUMAB-AATY,
713
26842980
US
69
Device malfunction, Exposure via skin contact, Accidental exposure to product,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, GABAPENTIN,
714
26843129
US
54 2
Device operational issue, Incorrect dose administered by device, Device malfunction, Incorrect dose administered,
ABATACEPT, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, ENALAPRIL, ROSUVASTATIN,
715
26843436
US
76 1
Device malfunction, Product cleaning inadequate, Product dose omission issue,
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE,
716
26843438
US
2
Administration site pain, Application site haemorrhage, Device malfunction, Device delivery system issue, Product dose omission issue,
SUMATRIPTAN SUCCINATE, SUMATRIPTAN, SUMATRIPTAN SUCCINATE, ESTRADIOL, ESTRADIOL GEL 0.1%, ESTRADIOL TRANSDERMAL, ESTRADIOL,, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, ROPINIROLE,
717
26843481
US
69
Device malfunction, Accidental exposure to product, Product dose omission issue, Off label use,
GUSELKUMAB, GUSELKUMAB,
718
26844010
US
86 1
Hypoacusis, Product dose omission issue, Device malfunction, Inappropriate schedule of product administration, Needle issue,
TEZEPELUMAB-EKKO, TEZEPELUMAB-EKKO,
719
26844835
US
77
Device malfunction, Exposure via skin contact, Accidental exposure to product, Drug dose omission by device,
ADALIMUMAB-AATY, ADALIMUMAB-AATY, AMLODIPINE, MECLIZINE HCL 12.5 MG, MECLIZINE HCL 25 MG, MECLIZINE HYDROCHLORIDE, MECLIZINE, MECLIZINE HCL 25MG, MECLIZINE HCL 12.5MG,
720
26844839
US
57
Device malfunction, Drug dose omission by device,
ADALIMUMAB-AATY, ADALIMUMAB-AATY,
721
26844841
US
79
Device malfunction, Exposure via skin contact, Accidental exposure to product,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP,
722
26844842
US
57
Device malfunction, Drug dose omission by device,
ADALIMUMAB-AATY, ADALIMUMAB-AATY,
723
26844844
US
74
Device malfunction, Drug dose omission by device,
ADALIMUMAB-AATY, ADALIMUMAB-AATY,
724
26844845
US
65
Device malfunction, Drug dose omission by device,
ADALIMUMAB-AATY, ADALIMUMAB-AATY,
725
26844849
US
66
Device malfunction, Drug dose omission by device,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP,
726
26844855
US
42
Device malfunction, Needle issue, Accidental exposure to product, Exposure via skin contact,
ADALIMUMAB-AATY, ADALIMUMAB-AATY,
727
26844857
US
43
Device malfunction, Accidental exposure to product, Exposure via skin contact, Therapy interrupted,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP,
728
26844869
US
74
Accidental exposure to product, Exposure via skin contact, Device malfunction,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP,
729
26844870
US
57
Device malfunction, Exposure via skin contact,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP,
730
26844872
US
70
Device malfunction, Exposure via skin contact, Accidental exposure to product, Wrong technique in product usage process,
ADALIMUMAB-AATY, ADALIMUMAB-AATY,
731
26844877
US
63
Device malfunction, Exposure via skin contact, Accidental exposure to product,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP,
732
26844878
US
Product leakage, Device malfunction, Exposure via skin contact, Accidental exposure to product,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP,
733
26844880
US
49
Device malfunction, Accidental exposure to product, Exposure via skin contact,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP,
734
26844911
US
79
Device malfunction, Exposure via skin contact, Accidental exposure to product, Drug dose omission by device, Suspected off label use,
ADALIMUMAB-AATY, ADALIMUMAB-AATY,
735
26844912
US
70
Device malfunction, Drug dose omission by device, Suspected off label use,
ADALIMUMAB-AATY, ADALIMUMAB-AATY,
736
26844925
US
37
Device malfunction, Product preparation issue, Drug dose omission by device,
ADALIMUMAB-AATY, ADALIMUMAB-AATY,
737
26834604
US
24
Device malfunction, Drug dose omission by device,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP,
738
26834692
GB
58
Device malfunction, Injection site haemorrhage,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, CELECOXIB,
739
26834870
US
36
Device malfunction, Drug dose omission by device,
ADALIMUMAB-AATY, ADALIMUMAB-AATY,
740
26834915
US
Device malfunction, Drug dose omission by device,
ADALIMUMAB-AATY, ADALIMUMAB-AATY,
741
26835045
US
80
Pain, Gait disturbance, Pain in extremity, Oedema peripheral, Device malfunction, Drug dose omission by device,
ADALIMUMAB-AATY, ADALIMUMAB-AATY, FOLIC ACID, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM,
742
26835090
US
45
Device malfunction, Exposure via skin contact, Accidental exposure to product, Drug dose omission by device,
ADALIMUMAB-AATY, ADALIMUMAB-AATY,
743
26835109
US
37
Device malfunction, Device leakage,
ADALIMUMAB-AATY, ADALIMUMAB-AATY,
744
26835254
US
37
Accidental exposure to product, Exposure via skin contact, Device malfunction,
ADALIMUMAB-AATY, ADALIMUMAB-AATY,
745
26835271
US
45
Device malfunction, Device leakage, Injection site pain, Needle track marks,
746
26835328
US
28
Device malfunction, Anxiety, Accidental exposure to product, Exposure via skin contact, Wrong technique in product usage process,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP,
747
26835404
US
64
Device malfunction, Drug dose omission by device,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP,
748
26835519
US
12
Device malfunction, Incorrect dose administered, Drug dose omission by device,
ADALIMUMAB-AATY, ADALIMUMAB-AATY,
749
26835602
US
72
Device malfunction, Accidental exposure to product, Exposure via skin contact,
ADALIMUMAB-AATY, ADALIMUMAB-AATY,
750
26835995
US
2
Device malfunction, Drug dose omission by device,
GUSELKUMAB,
751
26836000
US
73
Device malfunction, Product dose omission issue,
NEMOLIZUMAB-ILTO,
752
26836007
US
78 2
Device delivery system issue, Device malfunction, Product use issue,
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE,
753
26836189
US
Increased appetite, Device malfunction, Accidental exposure to product,
754
26836372
US
46 2
Hunger, Device malfunction, Incorrect dose administered by device,
755
26836484
US
Device malfunction, Device malfunction, Injury associated with device, Injury associated with device,
PEGFILGRASTIM-CBQV,
756
26836735
US
59
Device malfunction, Wrong technique in product usage process, Exposure via skin contact, Drug dose omission by device,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP,
757
26836769
US
80
Device malfunction, Exposure via skin contact, Accidental exposure to product,
ADALIMUMAB-AATY, ADALIMUMAB-AATY, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, FUROSEMIDE,
758
26836861
US
16
Device malfunction, Drug dose omission by device,
ADALIMUMAB-AATY, ADALIMUMAB-AATY,
759
26836892
US
17
Device malfunction, Drug dose omission by device,
ADALIMUMAB-AATY, ADALIMUMAB-AATY,
760
26836913
US
1
Dementia, Rehabilitation therapy, Wrong technique in product usage process, Device use issue, Drug dose omission by device, Device malfunction,
ABALOPARATIDE, ABALOPARATIDE,
761
26836926
US
31
General symptom, Device malfunction, Exposure via skin contact, Accidental exposure to product, Incorrect dose administered by device,
ADALIMUMAB-AATY, ADALIMUMAB-AATY,
762
26836932
US
54
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,
763
26836964
US
1
Hypoacusis, Throat irritation, Device effect decreased, Device malfunction, Device defective, Incorrect dose administered, Wrong technique in product usage process performed in error,
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE,
764
26837005
US
2
Drug dose omission by device, Needle issue, Device malfunction, Device leakage, Device use error,
SECUKINUMAB,
765
26837022
US
64
Off label use, Wrong technique in product usage process, Device malfunction,
ALBUTEROL SULFATE, ALBUTEROL SULFATE,
766
26837030
US
35
Device malfunction, Drug dose omission by device,
ADALIMUMAB-AATY, ADALIMUMAB-AATY,
767
26837052
US
32 2
Drug dose omission by device, Device leakage, Device malfunction,
768
26837064
US
2
Product dose omission issue, Device malfunction, Device leakage,
769
26837112
US
79
Device malfunction, Accidental exposure to product, Exposure via skin contact, Incorrect dose administered by device,
ADALIMUMAB-AATY, ADALIMUMAB-AATY,
770
26837121
US
Drug dose omission by device, Device malfunction, Incorrect dose administered, Device delivery system issue, Off label use,
ALBUTEROL SULFATE,
771
26837122
US
72
Device malfunction, Exposure via skin contact, Drug dose omission by device,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP,
772
26837179
US
56
Device malfunction, Accidental exposure to product, Exposure via skin contact, Drug dose omission by device,
ADALIMUMAB-AATY, ADALIMUMAB-AATY, HYDROXYCHLOROQUINE,
773
26837296
US
66
Device malfunction, Drug dose omission by device,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP,
774
26837337
US
1
Device malfunction,
PEGFILGRASTIM,
775
26837379
US
70
Device malfunction, Exposure via skin contact, Accidental exposure to product,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP,
776
26837441
58 1
Fall, Toxicity to various agents, Toxicity to various agents, Seizure, Loss of consciousness, Somnolence, Device issue, Hypothermia, Dizziness, Withdrawal syndrome, Device malfunction,
BACLOFEN, BACLOFEN,
777
26837491
US
48 2
Drug dose omission by device, Device failure, Device issue, Device malfunction, Device mechanical issue, No adverse event,
LIRAGLUTIDE, LIRAGLUTIDE,
778
26837589
US
25
Device malfunction, Product dose omission issue,
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO,
779
26837779
US
18
Device malfunction, Drug dose omission by device,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP,
780
26837796
US
12 2
Drug dose omission by device, Device malfunction, Device leakage, Device mechanical issue,
SOMATROPIN,
781
26837804
AR
54 2
Device malfunction, Device delivery system issue, Device physical property issue, Drug dose omission by device, Incorrect route of product administration,
ETANERCEPT,
782
26837836
CA
Device malfunction, Accidental exposure to product, Exposure via skin contact,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP,
783
26837874
US
63
Device malfunction, Injection site haemorrhage,
ADALIMUMAB-AATY, ADALIMUMAB-AATY,
784
26837900
US
19
Device malfunction, Drug dose omission by device, Accidental exposure to product, Exposure via skin contact,
ADALIMUMAB-AATY, ADALIMUMAB-AATY, ADALIMUMAB-AATY,
785
26837932
US
80
Device malfunction, Drug dose omission by device,
ADALIMUMAB-AATY, ADALIMUMAB-AATY,
786
26837999
US
Device malfunction, Off label use,
LONAPEGSOMATROPIN-TCGD,
787
26838050
US
1
Fatigue, Visual impairment, Pulmonary function test, Intentional product misuse, Device use error, Device malfunction,
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE,
788
26830495
US
2
Incorrect dose administered by product, Device malfunction,
SOMATROPIN,
789
26830701
US
2
Device malfunction,
SECUKINUMAB, SECUKINUMAB,
790
26830741
US
No adverse event, Device malfunction, Device malfunction, No adverse event,
PEGFILGRASTIM-CBQV,
791
26830891
US
72 2
Injection site pain, Injection site bruising, Air in device issue, Product use in unapproved indication, Injection site discharge, Increased appetite, Device leakage, Device malfunction, Urticaria, Product dose omission issue,
792
26830950
US
No adverse event, Device malfunction, Device malfunction, No adverse event,
PEGFILGRASTIM-CBQV,
793
26831043
US
61 2
Incorrect dose administered, Accidental exposure to product, Device malfunction,
GUSELKUMAB,
794
26831172
US
No adverse event, Device malfunction, Device malfunction, No adverse event,
PEGFILGRASTIM-CBQV,
795
26831191
US
66
Device malfunction, Product dose omission issue,
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, DIPHENHYDRAMINE HYDROCHLORIDE,
796
26831306
US
58
Device malfunction, Incorrect dose administered,
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,
797
26831343
US
67 2
Device malfunction, Injection site haemorrhage, Incorrect dose administered by device, Increased appetite, Drug effect less than expected, Injection site bruising,
798
26831446
US
64
Device malfunction, Wrong technique in product usage process performed in error, No adverse event,
ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALPRAZOLAM,
799
26831533
US
2
Device malfunction, Dyspnoea, Incorrect dose administered,
800
26831610
US
55 2
Device malfunction, Product dose omission issue,
SECUKINUMAB,

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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