Drug:
Reaction: DEVICE MALFUNCTION
20260101 - 20261231
No. 801 - 900
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 801 | 26831744 |
US |
79 | 2 |
Wrong technique in product usage process, Device use error, Device issue, Device malfunction, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE, BUDESONIDE AND FORMOTEROL FUMARATE, BUDESONIDE AND FORMOTEROL FUMARATE, BUDESONIDE AND FORMOTEROL FUMARATE, |
||||
| 802 | 26831795 |
AR |
2 | |
Device malfunction, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 803 | 26832125 |
US |
2 | |
Product storage issue, Off label use, Device malfunction, |
||||
GUSELKUMAB, |
||||
| 804 | 26832862 |
US |
63 | 2 |
Device breakage, Product dose omission issue, Product dose omission issue, Nasopharyngitis, Device malfunction, |
||||
TEZEPELUMAB-EKKO, TEZEPELUMAB-EKKO, |
||||
| 805 | 26833027 |
US |
61 | |
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 806 | 26833166 |
US |
57 | 2 |
Product quality issue, Device malfunction, Dyspnoea, Drug ineffective, Asthma, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 807 | 26833169 |
US |
87 | 2 |
Device malfunction, Dyspnoea, Product quality issue, |
||||
ALBUTEROL SULFATE, |
||||
| 808 | 26833700 |
US |
20 | |
Device malfunction, Syringe issue, Incorrect dose administered, |
||||
GUSELKUMAB, |
||||
| 809 | 26833971 |
US |
2 | |
Product dose omission issue, Product use in unapproved indication, Product use issue, Device delivery system issue, Device mechanical issue, Device malfunction, |
||||
FLUTICASONE PROPIONATE AND SALMETEROL, FLUTICASONE PROPIONATE AND SALMETEROL, FLUTICASONE PROPIONATE AND SALMETEROL, FLUTICASONE PROPIONATE AND SALMETEROL, |
||||
| 810 | 26834182 |
US |
28 | 2 |
Product dose omission issue, Incorrect dose administered by device, Device leakage, Device malfunction, |
||||
| 811 | 26825005 |
US |
61 | 2 |
Increased appetite, Product dose omission issue, Device malfunction, |
||||
ORAL SEMAGLUTIDE, ORAL SEMAGLUTIDE, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, |
||||
| 812 | 26825426 |
US |
80 | 2 |
Device malfunction, |
||||
PEGFILGRASTIM, |
||||
| 813 | 26825461 |
US |
||
Device malfunction, No adverse event, Device malfunction, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 814 | 26825807 |
US |
1 | |
No adverse event, Device malfunction, Device malfunction, No adverse event, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 815 | 26826422 |
US |
2 | |
Infusion site infection, Dyspnoea at rest, Infusion site abscess, Flushing, Rash, Fatigue, Wound, Dermatitis contact, Dyspnoea exertional, Rash erythematous, Headache, Malaise, Pain in extremity, Injection site irritation, Infusion site pain, Device maintenance issue, Device leakage, Device malfunction, |
||||
TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, MACITENTAN, SILDENAFIL CITRATE, SILDENAFIL, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATED, FUROSEMIDE, SODIUM CHLORIDE, SODIUM CHLORIDE TABLET, SODIUM CHLORIDE TABLETS, DIGOXIN, POTASSIUM CHLORIDE, POTASSIUM CHLORIDE EXTENDED-RELEASE, POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE, POTASSIUM CHLORIDE ORAL, SPIRONOLACTONE, SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE, METFORMIN HYDROCHLORIDE, METFORMIN, METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, METFORMIN HYDROCHLORIDE TABLET, METFORMIN HYDROCHLORIDE TABLETS, DICLOFENAC SODIUM, DICLOFENAC SODIUM TOPICAL, DICLOFENAC SODIUM TOPICAL GEL, 1%, DICLOFENAC, DICLOFENAC SODIUM 1%, ALBUTEROL SULFATE, |
||||
| 816 | 26826811 |
US |
2 | |
Incorrect dose administered by device, Device malfunction, Device leakage, |
||||
| 817 | 26828300 |
US |
16 | 2 |
Migraine, Device malfunction, |
||||
FREMANEZUMAB-VFRM, FREMANEZUMAB-VFRM, |
||||
| 818 | 26828327 |
US |
14 | |
Device malfunction, Accidental exposure to product, Exposure via skin contact, Product distribution issue, |
||||
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, |
||||
| 819 | 26828939 |
US |
||
Incorrect dose administered, Device malfunction, |
||||
RISPERIDONE, RISPERIDONE, |
||||
| 820 | 26829376 |
US |
1 | |
Product administration issue, Device malfunction, Incorrect dose administered, No adverse event, |
||||
PEMBROLIZUMAB, |
||||
| 821 | 26829421 |
US |
2 | |
Injection site pain, Wrong technique in product usage process, Product dose omission issue, Device malfunction, |
||||
TEZEPELUMAB-EKKO, |
||||
| 822 | 26829728 |
US |
28 | 1 |
Device malfunction, Device issue, Incorrect dose administered, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 823 | 26819497 |
US |
77 | 2 |
Device malfunction, Drug dose omission by device, |
||||
| 824 | 26819536 |
US |
62 | 2 |
Hallucination, Vision blurred, Drug dose omission by device, Device malfunction, |
||||
OFATUMUMAB, GABAPENTIN, FOLIC ACID, PROPRANOLOL HYDROCHLORIDE, |
||||
| 825 | 26819710 |
US |
||
Device malfunction, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, |
||||
| 826 | 26819796 |
US |
36 | 2 |
Product administered at inappropriate site, Device malfunction, |
||||
| 827 | 26819813 |
US |
71 | 2 |
Device malfunction, Device leakage, Incorrect dose administered by device, Injection site haemorrhage, |
||||
| 828 | 26819814 |
US |
62 | 1 |
Device malfunction, Drug dose omission by device, Device leakage, |
||||
| 829 | 26819892 |
US |
62 | 1 |
Device malfunction, Device leakage, Injection site reaction, Injection site haemorrhage, Injection site reaction, Incorrect dose administered by device, Injection site haemorrhage, Injection site haemorrhage, Injection site reaction, Device leakage, |
||||
| 830 | 26819930 |
US |
69 | 2 |
Device leakage, Drug dose omission by device, Device malfunction, |
||||
| 831 | 26819957 |
US |
22 | 2 |
Device malfunction, Device leakage, Drug dose omission by device, |
||||
| 832 | 26820200 |
1 | ||
Injection site pain, Device malfunction, Incorrect dose administered, |
||||
ADALIMUMAB-RYVK, |
||||
| 833 | 26820210 |
US |
||
Device malfunction, Injection site discharge, |
||||
| 834 | 26820263 |
US |
56 | 2 |
Device malfunction, Incorrect dose administered by device, |
||||
ORAL SEMAGLUTIDE, |
||||
| 835 | 26820270 |
US |
61 | 2 |
Device malfunction, Injection site discharge, |
||||
OXYGEN, 0XYGEN, |
||||
| 836 | 26820275 |
US |
75 | 1 |
Product dose omission issue, Accidental exposure to product, Device malfunction, |
||||
GUSELKUMAB, |
||||
| 837 | 26820391 |
US |
82 | 2 |
Product dose omission issue, Device malfunction, |
||||
| 838 | 26820396 |
US |
23 | 2 |
Injection site discharge, Incorrect dose administered by device, Device malfunction, |
||||
| 839 | 26820493 |
US |
58 | 2 |
Device malfunction, Drug dose omission by device, |
||||
| 840 | 26820568 |
US |
35 | 2 |
Drug dose omission by device, Device malfunction, Device leakage, Needle issue, |
||||
| 841 | 26820572 |
US |
55 | 2 |
Drug dose omission by device, Device malfunction, Device leakage, |
||||
| 842 | 26820576 |
US |
72 | 2 |
Device malfunction, Device malfunction, Inappropriate schedule of product administration, Drug dose omission by device, |
||||
| 843 | 26820582 |
US |
47 | 2 |
Injection site discharge, Incorrect dose administered by product, Device malfunction, |
||||
| 844 | 26820584 |
US |
60 | |
Drug dose omission by device, Device malfunction, |
||||
| 845 | 26820606 |
US |
58 | 1 |
Incorrect dose administered by device, Device malfunction, Device leakage, |
||||
| 846 | 26820768 |
US |
46 | 2 |
Dizziness, Thirst, Increased appetite, Blood glucose increased, Drug dose omission by device, Device malfunction, |
||||
ORAL SEMAGLUTIDE, |
||||
| 847 | 26820771 |
US |
54 | 2 |
Incorrect dose administered by device, Device malfunction, |
||||
| 848 | 26820781 |
US |
81 | 2 |
Vomiting, Nausea, Device malfunction, |
||||
ORAL SEMAGLUTIDE, |
||||
| 849 | 26820845 |
US |
31 | 1 |
Injection site pain, Device leakage, Incorrect dose administered by device, Device malfunction, Injection site discharge, |
||||
| 850 | 26821294 |
US |
29 | 2 |
Device malfunction, Injection site indentation, |
||||
| 851 | 26821586 |
US |
||
Injury associated with device, Device malfunction, |
||||
| 852 | 26821630 |
US |
81 | 2 |
Gastrointestinal haemorrhage, Dyspnoea, Device malfunction, |
||||
TIOTROPIUM BROMIDE AND OLODATEROL, |
||||
| 853 | 26821782 |
US |
46 | 1 |
Device malfunction, Product dose omission issue, Condition aggravated, |
||||
GUSELKUMAB, |
||||
| 854 | 26822349 |
US |
22 | 1 |
Device malfunction, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
| 855 | 26823932 |
US |
56 | 2 |
Product use issue, Device leakage, Device malfunction, Device defective, |
||||
| 856 | 26824155 |
US |
71 | 2 |
Wrong technique in device usage process, Device malfunction, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE, |
||||
| 857 | 26824211 |
US |
2 | |
Device malfunction, Device delivery system issue, Product dose omission issue, |
||||
BENRALIZUMAB, BENRALIZUMAB, |
||||
| 858 | 26824327 |
US |
40 | 1 |
Device use error, Incorrect dose administered by device, Device malfunction, Device delivery system issue, |
||||
FLUTICASONE PROPIONATE AND SALMETEROL, |
||||
| 859 | 26824780 |
US |
2 | |
Device malfunction, Product dose omission issue, Accidental exposure to product, |
||||
GOLIMUMAB, |
||||
| 860 | 26824789 |
GB |
||
Renal disorder, Device malfunction, Product leakage, Drug dose omission by device, |
||||
ADALIMUMAB-AATY, ADALIMUMAB-AATY, |
||||
| 861 | 26824878 |
US |
45 | 2 |
Device malfunction, Product leakage, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
| 862 | 26817677 |
US |
||
Device malfunction, No adverse event, Device malfunction, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 863 | 26818055 |
US |
||
Device malfunction, |
||||
NITRIC OXIDE, NITRIC OXIDE, |
||||
| 864 | 26818092 |
US |
58 | 1 |
Injection site haemorrhage, Device malfunction, Product contamination with body fluid, Off label use, |
||||
INSULIN GLARGINE, |
||||
| 865 | 26818217 |
US |
41 | 2 |
Pruritus, Injection site pain, Device malfunction, |
||||
DUPILUMAB, |
||||
| 866 | 26819199 |
US |
||
Device malfunction, |
||||
NITRIC OXIDE, NITRIC OXIDE, |
||||
| 867 | 26813111 |
US |
1 | |
Device leakage, Drug dose omission by device, Device malfunction, |
||||
| 868 | 26813131 |
US |
30 | 2 |
Device malfunction, Injection site haemorrhage, Device leakage, |
||||
| 869 | 26813316 |
BR |
||
Device malfunction, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, |
||||
| 870 | 26813390 |
US |
47 | 2 |
Device malfunction, Device leakage, Drug dose omission by device, Skin pressure mark, Accidental exposure to product, |
||||
| 871 | 26813441 |
US |
74 | 2 |
Injection site pain, Device malfunction, |
||||
| 872 | 26813614 |
US |
73 | 1 |
Device malfunction, Incorrect dose administered by device, Injection site mass, Injection site discharge, |
||||
| 873 | 26813616 |
US |
44 | 2 |
Product dose omission issue, Device leakage, Device malfunction, Injection site oedema, |
||||
| 874 | 26813621 |
US |
73 | 1 |
Product dose omission issue, Device malfunction, Product storage error, |
||||
ORAL SEMAGLUTIDE, |
||||
| 875 | 26813622 |
US |
75 | 2 |
Device malfunction, Product dose omission issue, |
||||
ORAL SEMAGLUTIDE, ORAL SEMAGLUTIDE, |
||||
| 876 | 26813623 |
US |
61 | 2 |
Device malfunction, Injection site indentation, Injection site mass, |
||||
| 877 | 26813711 |
US |
||
No adverse event, Device malfunction, Device malfunction, No adverse event, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 878 | 26813724 |
US |
||
Device malfunction, Device malfunction, No adverse event, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 879 | 26813743 |
US |
||
Device malfunction, No adverse event, No adverse event, Device malfunction, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 880 | 26813780 |
US |
||
Device malfunction, No adverse event, Device malfunction, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 881 | 26813810 |
US |
||
Product dose omission issue, Drug delivery system issue, Device malfunction, Product dose omission issue, Drug delivery system issue, Device malfunction, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 882 | 26814088 |
US |
47 | 2 |
Drug dose omission by device, Device leakage, Device malfunction, |
||||
| 883 | 26814157 |
US |
47 | 2 |
Device malfunction, Incorrect dose administered by device, Device leakage, |
||||
| 884 | 26814490 |
US |
||
Device malfunction, No adverse event, Device malfunction, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 885 | 26814570 |
US |
2 | |
Device malfunction, Device delivery system issue, |
||||
PEGINTERFERON BETA-1A, |
||||
| 886 | 26814637 |
US |
||
Device malfunction, Product use issue, Product dose omission issue, Incorrect dose administered by device, |
||||
BENRALIZUMAB, BENRALIZUMAB, |
||||
| 887 | 26814780 |
US |
65 | 2 |
Device malfunction, Injection site indentation, Device leakage, |
||||
| 888 | 26814804 |
US |
2 | |
Inappropriate schedule of product administration, Device malfunction, |
||||
BENRALIZUMAB, BENRALIZUMAB, |
||||
| 889 | 26815053 |
US |
9 | 2 |
Drug dose omission by device, Device malfunction, Needle issue, Needle issue, Product outer packaging issue, |
||||
| 890 | 26815057 |
US |
35 | 2 |
Device malfunction, Incorrect dose administered by device, Device leakage, |
||||
| 891 | 26815058 |
US |
72 | 1 |
Hunger, Device malfunction, Drug dose omission by device, |
||||
| 892 | 26815166 |
US |
1 | |
Device defective, No adverse event, Device malfunction, |
||||
LIRAGLUTIDE, |
||||
| 893 | 26815189 |
US |
1 | |
Drug monitoring procedure incorrectly performed, Hypersensitivity, Dyspnoea, Therapeutic response decreased, Device malfunction, Product use issue, Product dose omission issue, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 894 | 26815268 |
US |
38 | 2 |
Device malfunction, Liquid product physical issue, Injection site indentation, Device leakage, |
||||
| 895 | 26815303 |
US |
53 | 2 |
Device leakage, Incorrect dose administered, Device malfunction, |
||||
OFATUMUMAB, |
||||
| 896 | 26815689 |
US |
6 | 2 |
Device mechanical issue, Device delivery system issue, Device malfunction, Device defective, |
||||
SOMATROPIN, |
||||
| 897 | 26816077 |
US |
2 | |
Device malfunction, Accidental exposure to product, No adverse event, Wrong technique in product usage process, |
||||
TOCILIZUMAB, |
||||
| 898 | 26816180 |
US |
32 | 2 |
Device malfunction, Device leakage, Injection site haemorrhage, |
||||
| 899 | 26816472 |
BR |
||
Device malfunction, |
||||
PEGFILGRASTIM, |
||||
| 900 | 26817014 |
CA |
70 | 2 |
Incorrect dose administered by device, Device malfunction, |
||||
ALBUTEROL SULFATE, |
||||
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.
terms
license
last_updated
2026-07-30