Drug:
Reaction: DEVICE MALFUNCTION
20260101 - 20261231
No. 1 - 100
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 1 | 26555436 |
US |
2 | |
Device malfunction, Device use error, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
| 2 | 26555959 |
US |
||
Injury associated with device, Device malfunction, Device safety feature issue, Syringe issue, |
||||
ENOXAPARIN SODIUM, |
||||
| 3 | 26556626 |
US |
||
Device malfunction, |
||||
NITRIC OXIDE, NITRIC OXIDE, |
||||
| 4 | 26557275 |
US |
69 | |
Device malfunction, Device leakage, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 5 | 26557354 |
1 | ||
Product delivery mechanism issue, Product dose omission issue, Device malfunction, Product packaging quantity issue, Inappropriate schedule of product administration, |
||||
IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE, |
||||
| 6 | 26557901 |
US |
71 | 2 |
Nasopharyngitis, Bronchitis, Device malfunction, Inappropriate schedule of product administration, |
||||
BENRALIZUMAB, BENRALIZUMAB, |
||||
| 7 | 26557911 |
US |
89 | |
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, |
||||
| 8 | 26558014 |
US |
||
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 9 | 26558318 |
US |
28 | 1 |
No adverse event, Device malfunction, Incorrect dose administered, |
||||
VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, |
||||
| 10 | 26558521 |
US |
38 | |
Product dose omission issue, Device malfunction, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 11 | 26558775 |
US |
71 | |
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 12 | 26558987 |
US |
54 | |
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 13 | 26559007 |
US |
57 | |
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 14 | 26559019 |
40 | ||
Incorrect dose administered, Device malfunction, |
||||
BIMEKIZUMAB, BIMEKIZUMAB, SECUKINUMAB, |
||||
| 15 | 26559142 |
US |
53 | 2 |
Dyspnoea, Device use issue, Product dose omission issue, Incorrect dose administered by device, Device malfunction, Device delivery system issue, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 16 | 26559519 |
US |
58 | 1 |
Headache, Device malfunction, Product storage error, |
||||
FREMANEZUMAB-VFRM, |
||||
| 17 | 26560000 |
US |
67 | |
Product dose omission issue, Device malfunction, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 18 | 26560009 |
US |
86 | |
Incorrect dose administered, Device malfunction, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 19 | 26560522 |
US |
||
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 20 | 26560681 |
US |
58 | |
Incorrect dose administered, Device malfunction, Drug effect less than expected, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 21 | 26561418 |
US |
49 | |
Product dose omission issue, Device malfunction, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 22 | 26561432 |
US |
57 | |
Device malfunction, Incorrect dose administered, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 23 | 26561446 |
US |
87 | |
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 24 | 26561459 |
US |
73 | 2 |
Device malfunction, Product substitution issue, Condition aggravated, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 25 | 26561463 |
US |
68 | |
Product dose omission issue, Device malfunction, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 26 | 26561464 |
US |
78 | |
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 27 | 26561502 |
US |
72 | |
Arthralgia, Joint stiffness, Limb discomfort, Nasopharyngitis, Head discomfort, Cough, Injection site pain, Product dose omission issue, Device malfunction, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 28 | 26561511 |
US |
58 | |
Device malfunction, Incorrect dose administered, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 29 | 26561607 |
US |
85 | 1 |
Device malfunction, Application site haemorrhage, |
||||
PEGFILGRASTIM, |
||||
| 30 | 26561624 |
US |
||
Drug ineffective, Device malfunction, |
||||
ALBUTEROL SULFATE AND BUDESONIDE, |
||||
| 31 | 26550677 |
US |
2 | |
Dyspnoea, Anger, Device delivery system issue, Device malfunction, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 32 | 26551256 |
US |
65 | 2 |
Device malfunction, Product label confusion, Product dose omission issue, Stress, |
||||
| 33 | 26551595 |
US |
1 | |
No adverse event, Device malfunction, |
||||
VEDOLIZUMAB, VEDOLIZUMAB, |
||||
| 34 | 26552313 |
US |
2 | |
Injection site haemorrhage, Device malfunction, |
||||
FREMANEZUMAB-VFRM, |
||||
| 35 | 26554954 |
US |
74 | 1 |
Device malfunction, Accidental exposure to product, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
| 36 | 26548891 |
US |
||
Device malfunction, No adverse event, Device malfunction, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 37 | 26549782 |
US |
||
Dyspnoea, Device breakage, Device malfunction, |
||||
ALBUTEROL SULFATE, |
||||
| 38 | 26549882 |
US |
||
Device malfunction, Device malfunction, No adverse event, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 39 | 26549883 |
US |
2 | |
Device malfunction, No adverse event, Device malfunction, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 40 | 26549896 |
US |
||
No adverse event, Device malfunction, No adverse event, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 41 | 26549918 |
US |
||
No adverse event, Device malfunction, No adverse event, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 42 | 26547578 |
US |
||
No adverse event, Device malfunction, No adverse event, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 43 | 26541973 |
US |
27 | 2 |
Inappropriate schedule of product administration, Asthma, Device issue, Device malfunction, Product dose omission issue, Wrong technique in device usage process, |
||||
BENRALIZUMAB, BENRALIZUMAB, |
||||
| 44 | 26542006 |
US |
||
Device malfunction, Device malfunction, No adverse event, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 45 | 26542758 |
AR |
2 | |
Device malfunction, Therapy interrupted, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 46 | 26543028 |
US |
58 | 2 |
Device malfunction, Product dose omission issue, Product dose omission issue, |
||||
PEGFILGRASTIM-CBQV, PEGFILGRASTIM-CBQV, |
||||
| 47 | 26543055 |
US |
||
No adverse event, Device malfunction, No adverse event, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 48 | 26543081 |
US |
34 | 2 |
Device malfunction, Product dose omission issue, No adverse event, Device malfunction, Product dose omission issue, No adverse event, |
||||
PEGFILGRASTIM-CBQV, PEGFILGRASTIM-CBQV, DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN, CYCLOPHOSPHAMIDE FOR INJECTION, CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE INJECTION, SOLUTION, PACLITAXEL, PACLITAXEL (AIBUMIN-BOUND), PEGFILGRASTIM-CBQV, PEGFILGRASTIM-CBQV, |
||||
| 49 | 26543089 |
US |
||
Device malfunction, No adverse event, Device malfunction, No adverse event, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 50 | 26543096 |
US |
||
No adverse event, Device malfunction, No adverse event, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 51 | 26543813 |
US |
72 | 2 |
Wrong technique in product usage process, Device malfunction, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE, |
||||
| 52 | 26543815 |
US |
81 | 2 |
Product use in unapproved indication, Wrong technique in device usage process, Device delivery system issue, Device malfunction, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE, BUDESONIDE AND FORMOTEROL FUMARATE, BUDESONIDE AND FORMOTEROL FUMARATE, BUDESONIDE AND FORMOTEROL FUMARATE, |
||||
| 53 | 26543943 |
US |
57 | 2 |
Device malfunction, Product dose omission issue, Treatment noncompliance, Device use error, White blood cell count decreased, Product dose omission issue, Treatment noncompliance, Device use error, Device malfunction, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 54 | 26543951 |
US |
||
No adverse event, Device malfunction, No adverse event, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 55 | 26543967 |
US |
||
Device malfunction, No adverse event, Device malfunction, No adverse event, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 56 | 26544079 |
US |
||
No adverse event, Device malfunction, No adverse event, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 57 | 26544100 |
US |
||
Device malfunction, No adverse event, Device malfunction, No adverse event, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 58 | 26544179 |
36 | ||
Device malfunction, Diarrhoea, |
||||
CALCITRIOL, CALCITRIOL CAPSULES 0.25 MCG, CALCITRIOL CAPSULES 0.5 MCG, CLONIDINE, LABETALOL, LACTULOSE, NIFEDIPINE, SODIUM BICARBONATE, SODIUM BICARBONATE INJECTION,, |
||||
| 59 | 26544346 |
US |
74 | 2 |
Product dose omission issue, Device defective, No adverse event, Device malfunction, |
||||
TOCILIZUMAB, TOCILIZUMAB, |
||||
| 60 | 26544823 |
US |
79 | 2 |
Dyspnoea, Device malfunction, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE, |
||||
| 61 | 26544899 |
US |
72 | 1 |
Drug dose omission by device, Device mechanical issue, Device defective, Device malfunction, |
||||
LIRAGLUTIDE, LIRAGLUTIDE, |
||||
| 62 | 26544900 |
EU |
32 | 1 |
Headache, Head discomfort, Device malfunction, |
||||
ERENUMAB-AOOE, |
||||
| 63 | 26544901 |
US |
82 | 2 |
Blood glucose increased, Incorrect dose administered by device, Device mechanical issue, Device malfunction, Product quality issue, |
||||
LIRAGLUTIDE, |
||||
| 64 | 26544903 |
US |
2 | |
Diarrhoea, Muscle spasms, Product dose omission issue, Accidental exposure to product, Device malfunction, |
||||
ADALIMUMAB-AQVH, |
||||
| 65 | 26545472 |
US |
1 | |
Sleep apnoea syndrome, Device malfunction, |
||||
SOMATROPIN, |
||||
| 66 | 26546275 |
BR |
57 | 2 |
Blood potassium increased, Blood sodium decreased, Pneumonia, Urinary tract infection, Device malfunction, Device failure, Incorrect dose administered by device, Blood magnesium decreased, Blood calcium decreased, Blood iron decreased, Morose, Hyperglycaemia, Wrong technique in product usage process, |
||||
INSULIN ASPART INJECTION, INSULIN ASPART, INSULIN ASPART INJECTION, INSULIN ASPART, INSULIN ASPART INJECTION, INSULIN ASPART, INSULIN ASPART INJECTION, INSULIN ASPART, INSULIN ASPART INJECTION, INSULIN ASPART, INSULIN ASPART INJECTION, INSULIN ASPART, INSULIN ASPART INJECTION, INSULIN ASPART, INSULIN ASPART INJECTION, INSULIN ASPART, INSULIN ASPART INJECTION, INSULIN ASPART, INSULIN ASPART INJECTION, INSULIN ASPART, INSULIN ASPART INJECTION, INSULIN ASPART, INSULIN ASPART INJECTION, INSULIN ASPART, INSULIN ASPART INJECTION, INSULIN ASPART, INSULIN ASPART INJECTION, INSULIN ASPART, INSULIN ASPART INJECTION, INSULIN ASPART, INSULIN ASPART INJECTION, INSULIN ASPART, INSULIN ASPART INJECTION, INSULIN ASPART, INSULIN ASPART INJECTION, INSULIN ASPART, EMPAGLIFLOZIN, ROSUVASTATIN, AMLODIPINE, |
||||
| 67 | 26536006 |
US |
19 | |
Device malfunction, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
| 68 | 26536310 |
US |
1 | |
Device malfunction, Accidental exposure to product, Drug dose omission by device, |
||||
SECUKINUMAB, |
||||
| 69 | 26536356 |
US |
2 | |
Drug dose omission by device, Device malfunction, Device delivery system issue, No adverse event, |
||||
RISPERIDONE, |
||||
| 70 | 26536561 |
US |
||
Device malfunction, Incorrect dose administered, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 71 | 26536714 |
US |
||
Device malfunction, No adverse event, Device malfunction, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 72 | 26536999 |
US |
||
Dizziness, Device malfunction, Incorrect dose administered, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 73 | 26537031 |
US |
||
Device malfunction, Incorrect dose administered, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 74 | 26537256 |
US |
||
Pain of skin, Pruritus, Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 75 | 26537359 |
US |
1 | |
Device intolerance, No adverse event, Device malfunction, Device malfunction, Device intolerance, No adverse event, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 76 | 26537399 |
US |
||
Device malfunction, Incorrect dose administered, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 77 | 26537910 |
US |
||
Injection site haemorrhage, Inappropriate schedule of product administration, Device malfunction, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 78 | 26537912 |
US |
||
Product dose omission issue, Device malfunction, Product dose omission issue, Device malfunction, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 79 | 26537972 |
US |
2 | |
Wheezing, Device malfunction, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 80 | 26538116 |
US |
||
Device use error, Device malfunction, Incorrect dose administered, Intentional product use issue, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 81 | 26538409 |
AU |
2 | |
Device malfunction, Drug ineffective, |
||||
| 82 | 26538410 |
US |
59 | 2 |
Therapeutic product effect decreased, Device malfunction, Product dose omission issue, Drug ineffective, Oxygen saturation decreased, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 83 | 26538594 |
US |
||
Product dose omission issue, Device malfunction, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 84 | 26539024 |
US |
65 | 1 |
Product dose omission issue, Device malfunction, Off label use, Accidental exposure to product, Underdose, Needle issue, |
||||
GUSELKUMAB, GUSELKUMAB, |
||||
| 85 | 26539153 |
US |
||
Injection site haemorrhage, Device malfunction, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 86 | 26539157 |
GB |
61 | 2 |
Lower respiratory tract infection, Injection site mass, Device malfunction, Incorrect dose administered by device, Wrong technique in device usage process, Product preparation error, |
||||
SECUKINUMAB, SECUKINUMAB, SECUKINUMAB, |
||||
| 87 | 26539252 |
US |
||
Product dose omission issue, Device malfunction, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 88 | 26539478 |
26 | 2 | |
Device dislocation, Device malfunction, Dysmenorrhoea, Abnormal uterine bleeding, |
||||
LEVONORGESTREL, LEVONORGESTREL, |
||||
| 89 | 26539496 |
US |
85 | 2 |
Blindness, Device malfunction, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 90 | 26531268 |
CA |
77 | 2 |
Product dose omission issue, Device malfunction, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 91 | 26531278 |
US |
46 | 2 |
Device malfunction, Drug dose omission by device, |
||||
SECUKINUMAB, WARFARIN, SPIRONOLACTONE, LISINOPRIL, DAPAGLIFLOZIN, MYCOPHENOLIC ACID, MYCOPHENILIC ACID, |
||||
| 92 | 26531426 |
US |
2 | |
Device issue, General physical health deterioration, Device malfunction, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 93 | 26531458 |
US |
64 | 1 |
Psoriasis, Product administration error, Device malfunction, Product dose omission issue, Off label use, |
||||
GUSELKUMAB, |
||||
| 94 | 26532107 |
CN |
1 | |
Device malfunction, Mood altered, Condition aggravated, |
||||
| 95 | 26532169 |
US |
2 | |
Visual impairment, Device malfunction, Wrong technique in device usage process, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 96 | 26532408 |
US |
||
No adverse event, Device malfunction, |
||||
VEDOLIZUMAB, VEDOLIZUMAB, |
||||
| 97 | 26532450 |
US |
18 | 2 |
No adverse event, Device malfunction, |
||||
VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, CETIRIZINE HYDROCHLORIDE, |
||||
| 98 | 26532502 |
US |
87 | 2 |
Device malfunction, Needle issue, Dementia, |
||||
TOCILIZUMAB, |
||||
| 99 | 26532690 |
US |
||
Pruritus, Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 100 | 26532804 |
US |
||
Device malfunction, |
||||
NITRIC OXIDE, NITRIC OXIDE, |
||||
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