Drug:
Reaction: DEVICE ISSUE
20260101 - 20261231
No. 101 - 200
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 101 | 26937713 |
US |
18 | 1 |
Poor venous access, Device issue, Product dose omission issue, No adverse event, |
||||
ETEPLIRSEN, |
||||
| 102 | 26937830 |
US |
60 | |
Device issue, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
| 103 | 26938150 |
US |
2 | |
Injury associated with device, Device issue, |
||||
INSULIN GLARGINE, |
||||
| 104 | 26938202 |
|||
Device issue, Drug dose omission by device, Device delivery system issue, |
||||
DIAZEPAM, DIAZEPAM ORAL, DIAZEPAM ORAL SOLUTION (CONCENTRATE), |
||||
| 105 | 26938313 |
US |
34 | 2 |
Injection site haemorrhage, Colitis ulcerative, Device issue, |
||||
ADALIMUMAB, |
||||
| 106 | 26938361 |
US |
14 | 1 |
Device physical property issue, Device issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 107 | 26938645 |
US |
68 | 1 |
Visual impairment, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 108 | 26938756 |
US |
46 | 1 |
Injection site discharge, Device issue, |
||||
ADALIMUMAB, |
||||
| 109 | 26938913 |
US |
70 | 2 |
Dizziness, Fatigue, Device defective, Drug dose omission by device, Device issue, |
||||
ABALOPARATIDE, ABALOPARATIDE, ZOLPIDEM TARTRATE, CYCLOBENZAPRINE, ATORVASTATIN CALCIUM, NALOXONE HYDROCHLORIDE NASAL, NALOXONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN, PRAMIPEXOLE, OMEPRAZOLE MAGNESIUM, MONTELUKAST SODIUM, CETIRIZINE HYDROCHLORIDE, |
||||
| 110 | 26939165 |
US |
2 | |
Therapy interrupted, Drug dose omission by device, Device failure, Device issue, Device failure, Product dose omission issue, |
||||
ABALOPARATIDE, ABALOPARATIDE, PIROXICAM, |
||||
| 111 | 26939378 |
US |
84 | 2 |
Hypoaesthesia, Device issue, Product dose omission issue, Device use issue, Device use error, |
||||
ABALOPARATIDE, ABALOPARATIDE, |
||||
| 112 | 26939387 |
US |
48 | 2 |
Dizziness, Feeling abnormal, Device issue, |
||||
ABALOPARATIDE, ABALOPARATIDE, |
||||
| 113 | 26939501 |
US |
2 | |
Adverse event, Dizziness, Product supply issue, Product dose omission issue, Device malfunction, Device issue, |
||||
ABALOPARATIDE, ABALOPARATIDE, |
||||
| 114 | 26939640 |
US |
2 | |
COVID-19, Visual impairment, Fatigue, Product administered at inappropriate site, Product dose omission issue, Product administration error, Product preparation error, Incorrect disposal of product, Device issue, Needle issue, |
||||
ABALOPARATIDE, ABALOPARATIDE, ABALOPARATIDE, ABALOPARATIDE, |
||||
| 115 | 26939779 |
TR |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 116 | 26939801 |
US |
2 | |
Product dose omission in error, Device issue, |
||||
ABALOPARATIDE, ABALOPARATIDE, |
||||
| 117 | 26939890 |
BR |
||
Device issue, Device defective, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 118 | 26939897 |
EU |
81 | 1 |
Hypokinesia, On and off phenomenon, Upper limb fracture, Hallucination, Malaise, Device issue, |
||||
FOSCARBIDOPA/FOSLEVODOPA, FOSCARBIDOPA/FOSLEVODOPA, OPICAPONE, |
||||
| 119 | 26939940 |
BR |
5 | 2 |
Device issue, Product dose omission issue, Accidental exposure to product, |
||||
GOLIMUMAB, TOFACITINIB CITRATE, |
||||
| 120 | 26940044 |
CA |
24 | 2 |
Device issue, Product dose omission issue, |
||||
GOLIMUMAB, |
||||
| 121 | 26932444 |
US |
78 | 2 |
Hip arthroplasty, Amnesia, Fall, Device issue, Drug ineffective, Migraine, Crohn^s disease, Genital haemorrhage, Nasopharyngitis, Thrombosis, Colitis ulcerative, Groin pain, Depression, Neck injury, Head injury, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 122 | 26933063 |
EU |
||
Device issue, |
||||
GOLIMUMAB, GOLIMUMAB, |
||||
| 123 | 26933411 |
US |
2 | |
Injury associated with device, Device issue, |
||||
INSULIN GLARGINE, INSULIN GLARGINE, INSULIN GLARGINE, |
||||
| 124 | 26933521 |
US |
2 | |
Injection site haemorrhage, Device issue, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 125 | 26933909 |
CA |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 126 | 26933969 |
US |
71 | 2 |
Urinary tract infection, Confusional state, Device issue, Drug intolerance, |
||||
FOSCARBIDOPA/FOSLEVODOPA, FOSCARBIDOPA/FOSLEVODOPA, |
||||
| 127 | 26933972 |
IN |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 128 | 26934023 |
US |
64 | 1 |
Injection site papule, Device issue, Injection site erythema, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 129 | 26927341 |
2 | ||
Surgery, Device issue, Device deployment issue, Complication associated with device, Complication of device removal, |
||||
ETONOGESTREL, |
||||
| 130 | 26927537 |
US |
||
Incorrect dose administered by device, Device defective, Device failure, Device issue, No adverse event, |
||||
LIRAGLUTIDE, LIRAGLUTIDE, |
||||
| 131 | 26927617 |
US |
79 | 2 |
Brain operation, Injection site reaction, Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 132 | 26927645 |
US |
65 | 2 |
Inflammation, Gastrointestinal disorder, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, LEVOTHYROXINE SODIUM, FLUOXETINE HYDROCHLORIDE, FLUOXETINE, TIRZEPATIDE, MIRTAZAPINE, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, |
||||
| 133 | 26927665 |
EU |
79 | 1 |
Urosepsis, Hypokinesia, Pyrexia, Unresponsive to stimuli, Malaise, Device issue, Stoma complication, |
||||
| 134 | 26927727 |
US |
51 | 2 |
Injury associated with device, Device issue, Off label use, |
||||
INSULIN GLARGINE, |
||||
| 135 | 26927762 |
US |
85 | 2 |
Product dose omission issue, Incorrect dose administered, Cough, Dyspnoea, Illness, Taste disorder, Device issue, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 136 | 26927896 |
US |
||
Device issue, No adverse event, |
||||
RISPERIDONE, |
||||
| 137 | 26928467 |
US |
||
Device use error, Wrong technique in product usage process, Drug delivery system malfunction, Device issue, |
||||
TOCILIZUMAB, |
||||
| 138 | 26928569 |
US |
14 | 2 |
Pneumonia, Gait disturbance, Delusion, Product dose omission issue, Device malfunction, Device issue, Product temperature excursion issue, Product availability issue, |
||||
TEZEPELUMAB-EKKO, TEZEPELUMAB-EKKO, |
||||
| 139 | 26929048 |
CA |
1 | |
Device issue, Product dose omission issue, |
||||
RISPERIDONE, RISPERIDONE, RISPERIDONE, RISPERIDONE, |
||||
| 140 | 26929279 |
CA |
||
Device issue, |
||||
| 141 | 26930003 |
US |
51 | 2 |
Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 142 | 26930432 |
GB |
2 | |
Device issue, Wrong technique in device usage process, |
||||
PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE, |
||||
| 143 | 26930858 |
US |
2 | |
Device issue, Product dose omission issue, |
||||
ABATACEPT, |
||||
| 144 | 26930978 |
EU |
12 | 2 |
Device mechanical issue, Device use issue, Device issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 145 | 26921301 |
US |
43 | 1 |
Device issue, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
| 146 | 26921457 |
US |
67 | 1 |
Injection site papule, Device issue, Device leakage, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 147 | 26921559 |
BR |
36 | 1 |
Device issue, |
||||
PEGFILGRASTIM, |
||||
| 148 | 26921839 |
US |
66 | 1 |
Colitis ulcerative, Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 149 | 26922192 |
US |
70 | 2 |
Device defective, Device issue, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
| 150 | 26922536 |
US |
35 | 1 |
Device issue, Product dose omission issue, |
||||
GUSELKUMAB, GUSELKUMAB, |
||||
| 151 | 26922658 |
US |
23 | 1 |
Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 152 | 26923613 |
US |
81 | 1 |
Injection site pain, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 153 | 26923665 |
CN |
48 | 1 |
Device issue, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
| 154 | 26924015 |
US |
68 | 2 |
Therapeutic product effect incomplete, Device issue, Incorrect dose administered, Poor quality device used, |
||||
ENSIFENTRINE, |
||||
| 155 | 26925292 |
US |
37 | 1 |
Product dose omission issue, Device issue, |
||||
BIMEKIZUMAB, |
||||
| 156 | 26925922 |
US |
44 | 2 |
Systemic lupus erythematosus, Crohn^s disease, Haemorrhage, Dyspnoea, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 157 | 26926020 |
EU |
2 | |
Device mechanical issue, Device issue, Device leakage, |
||||
| 158 | 26926257 |
US |
49 | 2 |
Sleep apnoea syndrome, Nasal congestion, Off label use, Nasopharyngitis, Device issue, |
||||
IPRATROPIUM BROMIDE AND ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 159 | 26914649 |
US |
59 | 2 |
Hip arthroplasty, Arthralgia, Device issue, Osteoarthritis, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 160 | 26914650 |
US |
78 | 2 |
Ear operation, Memory impairment, Device issue, |
||||
RISANKIZUMAB-RZAA, |
||||
| 161 | 26914770 |
US |
2 | |
Cardiac failure, Sepsis, Pneumonia, Nasopharyngitis, Hypersensitivity, Therapeutic product effect decreased, Device issue, Stenosis, Infection, Illness, |
||||
ADALIMUMAB, ADALIMUMAB, USTEKINUMAB, USTEKINUMAB, |
||||
| 162 | 26914942 |
US |
45 | 2 |
Accidental exposure to product, Device issue, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
| 163 | 26915059 |
CN |
2 | |
Device issue, Needle issue, Injection site pain, Incorrect dose administered, Puncture site swelling, Accidental exposure to product, |
||||
GUSELKUMAB, |
||||
| 164 | 26915063 |
US |
2 | |
Emotional distress, Wrong technique in device usage process, Weight increased, Injection site discolouration, Device issue, |
||||
INSULIN DEGLUDEC, |
||||
| 165 | 26915099 |
US |
2 | |
Incorrect dose administered, Device issue, Illness, |
||||
ORAL SEMAGLUTIDE, |
||||
| 166 | 26915142 |
73 | 1 | |
Hypercapnia, Oxygen therapy, Chronic respiratory failure, Productive cough, Aphonia, Dysphonia, Therapy interrupted, Incorrect product administration duration, Device issue, Drug ineffective, |
||||
AMIKACIN, AMIKACIN, AZITHROMYCIN, AZITHROMYCIN MONOHYDRATE, AZITHROMYCIN DIHYDRATE, LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HCL, LOPERAMIDE HYDROCHLORIDE ORAL, FEBUXOSTAT, FEBUXOSTAT TABLETS 40 MG, FEBUXOSTAT TABLETS 80 MG, EPINASTINE HYDROCHLORIDE, RIFAMPIN, ETHAMBUTOL HYDROCHLORIDE, CLARITHROMYCIN, |
||||
| 167 | 26915146 |
US |
64 | 2 |
Immunodeficiency, Nasopharyngitis, Product leakage, Accidental exposure to product, Needle issue, Device issue, Fungal infection, Inflammation, Device defective, |
||||
ABATACEPT, |
||||
| 168 | 26915664 |
US |
2 | |
Device issue, Wrong technique in device usage process, No adverse event, |
||||
TOCILIZUMAB, |
||||
| 169 | 26915949 |
US |
75 | 2 |
Blood glucose increased, Malaise, Product dose omission issue, Device issue, |
||||
INSULIN GLARGINE, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, |
||||
| 170 | 26916465 |
US |
68 | 2 |
Ankle operation, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 171 | 26916670 |
US |
||
Device issue, |
||||
| 172 | 26916886 |
AR |
2 | |
Device issue, Arthralgia, Gait disturbance, Product dose omission issue, |
||||
GOLIMUMAB, |
||||
| 173 | 26917330 |
US |
11 | 1 |
Device mechanical issue, Device malfunction, Device delivery system issue, Device issue, Product quality issue, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE, |
||||
| 174 | 26917547 |
CO |
2 | |
Drug dose omission by device, Device mechanical issue, Device issue, |
||||
SOMATROPIN, |
||||
| 175 | 26917788 |
US |
79 | |
Intercepted product preparation error, Device leakage, Device issue, |
||||
LEUPROLIDE ACETATE, LEUPROLIDE ACETATE, |
||||
| 176 | 26917941 |
US |
59 | 2 |
Hypoacusis, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 177 | 26917957 |
US |
61 | 1 |
Device issue, Needle issue, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
| 178 | 26918232 |
US |
||
Sinusitis, Device issue, Extra dose administered, |
||||
ORAL SEMAGLUTIDE, |
||||
| 179 | 26918549 |
US |
1 | |
Injection site haemorrhage, Device issue, |
||||
DUPILUMAB, |
||||
| 180 | 26918608 |
US |
37 | 1 |
Device issue, Product dose omission issue, Product outer packaging issue, |
||||
GUSELKUMAB, |
||||
| 181 | 26918619 |
US |
41 | |
Device issue, Product dose omission issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 182 | 26918851 |
US |
63 | 2 |
Inappropriate schedule of product administration, Device issue, |
||||
BIMEKIZUMAB, |
||||
| 183 | 26919905 |
US |
81 | 1 |
Hypoacusis, Device issue, Hiccups, |
||||
RISANKIZUMAB-RZAA, |
||||
| 184 | 26920646 |
US |
||
Device issue, Product dose omission issue, |
||||
PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE, |
||||
| 185 | 26921024 |
US |
53 | 2 |
Fatigue, Device issue, Brain fog, |
||||
ADALIMUMAB, ADALIMUMAB, |
||||
| 186 | 26921040 |
JP |
||
Device issue, |
||||
RISPERIDONE, RISPERIDONE, RISPERIDONE, RISPERIDONE, |
||||
| 187 | 26921052 |
US |
57 | 2 |
Device issue, Product dose omission issue, Device leakage, |
||||
BIMEKIZUMAB, |
||||
| 188 | 26921077 |
EU |
||
Device issue, |
||||
DARUNAVIR, DARUNAVIR, |
||||
| 189 | 26921144 |
US |
2 | |
Deafness, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 190 | 26921251 |
US |
||
Device issue, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
| 191 | 26909630 |
AU |
1 | |
Device issue, Product dose omission issue, |
||||
GOLIMUMAB, |
||||
| 192 | 26909927 |
US |
||
Abdominal pain upper, Insomnia, Device issue, Anxiety, Bladder pain, Neuralgia, Dyspnoea, Headache, Electric shock sensation, |
||||
ALPRAZOLAM, |
||||
| 193 | 26910400 |
US |
70 | 1 |
Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 194 | 26910546 |
US |
26 | 1 |
Injection site erythema, Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 195 | 26910793 |
JP |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 196 | 26910826 |
AR |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 197 | 26910829 |
US |
28 | 1 |
Eczema, Product dose omission issue, Device issue, |
||||
DUPILUMAB, DUPILUMAB, DUPILUMAB, DUPILUMAB, DUPILUMAB, |
||||
| 198 | 26910855 |
US |
57 | 1 |
Limb injury, Injection site bruising, Injection site pain, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 199 | 26911273 |
EU |
2 | |
Device issue, Product dose omission issue, |
||||
GOLIMUMAB, |
||||
| 200 | 26911311 |
US |
2 | |
Product dose omission issue, Device issue, |
||||
BIMEKIZUMAB, |
||||
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