Drug:
Reaction: DEVICE MALFUNCTION
20260101 - 20261231
No. 101 - 200
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 101 | 26532805 |
US |
||
Device malfunction, |
||||
NITRIC OXIDE, NITRIC OXIDE, |
||||
| 102 | 26533449 |
US |
||
Intentional product use issue, Product dose omission issue, Device malfunction, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 103 | 26533508 |
US |
1 | |
Expired device used, Device mechanical issue, Device malfunction, |
||||
FLUTICASONE PROPIONATE AND SALMETEROL, FLUTICASONE PROPIONATE AND SALMETEROL, FLUTICASONE PROPIONATE AND SALMETEROL, FLUTICASONE PROPIONATE AND SALMETEROL, |
||||
| 104 | 26533750 |
US |
49 | 1 |
Device defective, Device leakage, Device malfunction, Device issue, Accidental exposure to product, Drug delivery system issue, Drug dose omission by device, |
||||
SECUKINUMAB, |
||||
| 105 | 26533889 |
US |
||
Incorrect dose administered, Device malfunction, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 106 | 26533914 |
US |
2 | |
Device malfunction, Accidental exposure to product, Drug dose omission by device, |
||||
SECUKINUMAB, |
||||
| 107 | 26533956 |
US |
||
Product dose omission issue, Device malfunction, Intentional product use issue, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 108 | 26533993 |
US |
16 | 1 |
Device malfunction, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 109 | 26534139 |
US |
2 | |
Device malfunction, Product use issue, Device delivery system issue, |
||||
| 110 | 26535055 |
US |
69 | |
Product use issue, Device mechanical issue, Device malfunction, |
||||
FLUTICASONE PROPIONATE AND SALMETEROL, |
||||
| 111 | 26535131 |
EU |
2 | |
Product quality issue, Device malfunction, |
||||
EPINEPHRINE, ADRENALINUM, |
||||
| 112 | 26535644 |
US |
87 | |
Device leakage, Burning sensation, Device malfunction, Injection site haemorrhage, |
||||
EPLONTERSEN, |
||||
| 113 | 26535667 |
US |
||
Injection site haemorrhage, Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 114 | 26527376 |
US |
||
Injection site haemorrhage, Device malfunction, Incorrect dose administered, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 115 | 26527378 |
US |
46 | 2 |
Device malfunction, Accidental exposure to product, Drug dose omission by device, |
||||
SECUKINUMAB, |
||||
| 116 | 26527387 |
|||
Injection site pain, Device malfunction, Off label use, |
||||
BIMEKIZUMAB, |
||||
| 117 | 26527390 |
US |
||
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 118 | 26527410 |
US |
55 | |
Device malfunction, Incorrect dose administered, Injection site induration, |
||||
GUSELKUMAB, |
||||
| 119 | 26527426 |
US |
||
Product dose omission issue, Device malfunction, |
||||
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, |
||||
| 120 | 26527676 |
US |
||
Rash, Product dose omission issue, Device malfunction, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 121 | 26527899 |
US |
54 | 2 |
Headache, Nausea, Dizziness, Product use issue, Device information output issue, Device malfunction, Device infusion issue, Product leakage, |
||||
TREPROSTINIL, TREPROSTINIL, ERGOCALCIFEROL, SODIUM CHLORIDE, SODIUM CHLORIDE TABLET, SODIUM CHLORIDE TABLETS, FAMOTIDINE, VITAMIN C, METOLAZONE, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, ZINC, ZINC GLUCONATE, ZINC CHLORIDE, TADALAFIL, FUROSEMIDE, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, MACITENTAN, SOTATERCEPT-CSRK, OXYGEN, 0XYGEN, IRON, IPRATROPIUM BROMIDE, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, GABAPENTIN, AZITHROMYCIN, AZITHROMYCIN MONOHYDRATE, AZITHROMYCIN DIHYDRATE, BENZONATATE, LORATADINE, LORATADINE ORAL, ONDANSETRON HYDROCHLORIDE, |
||||
| 122 | 26528076 |
US |
1 | |
Device malfunction, Dyspnoea, Product dose omission issue, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 123 | 26528089 |
US |
2 | |
Dyspnoea, Product dose omission issue, Overdose, Incorrect dose administered by product, Device malfunction, Drug ineffective, Intentional overdose, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 124 | 26528303 |
US |
||
Injection site haemorrhage, Circumstance or information capable of leading to device use error, Device malfunction, |
||||
ADALIMUMAB-ADAZ, ADALIMUMAB-ADAZ, |
||||
| 125 | 26528498 |
US |
35 | 2 |
Needle issue, Product leakage, Product dose omission issue, Device malfunction, |
||||
GUSELKUMAB, |
||||
| 126 | 26529028 |
US |
||
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 127 | 26529078 |
US |
||
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 128 | 26529567 |
EU |
1 | |
Product dose omission issue, Device malfunction, |
||||
| 129 | 26530903 |
US |
73 | 2 |
Device malfunction, Incorrect dose administered by device, Device deployment issue, |
||||
SECUKINUMAB, |
||||
| 130 | 26531007 |
BR |
51 | 2 |
Asphyxia, Fatigue, Asthma, Off label use, Device use issue, Device malfunction, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 131 | 26531021 |
US |
53 | 1 |
Device malfunction, Accidental exposure to product, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
| 132 | 26522873 |
US |
65 | 1 |
Visual impairment, Device issue, Incorrect dose administered by device, Device malfunction, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 133 | 26523304 |
US |
2 | |
Product dose omission issue, Product packaging quantity issue, Device malfunction, |
||||
| 134 | 26523489 |
US |
2 | |
Drug delivery system issue, Device difficult to use, Product leakage, Device malfunction, Accidental exposure to product, Device malfunction, |
||||
SECUKINUMAB, |
||||
| 135 | 26523785 |
US |
1 | |
Condition aggravated, Medication error, Device use issue, Incorrect dose administered, Device malfunction, Device difficult to use, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 136 | 26524053 |
US |
||
Device malfunction, Device malfunction, No adverse event, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 137 | 26524496 |
US |
||
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 138 | 26524791 |
US |
||
Incorrect dose administered, Device malfunction, Product prescribing error, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 139 | 26524841 |
2 | ||
Device malfunction, Device dislocation, Device physical property issue, |
||||
LEVONORGESTREL, |
||||
| 140 | 26524951 |
US |
||
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 141 | 26525714 |
US |
||
Drug ineffective, Device malfunction, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 142 | 26526073 |
US |
||
Drug dose omission by device, Device delivery system issue, Device malfunction, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 143 | 26526188 |
45 | ||
Myasthenia gravis, Asthenia, Device malfunction, Needle issue, Product dose omission issue, |
||||
ROZANOLIXIZUMAB, |
||||
| 144 | 26522362 |
US |
80 | 2 |
Injection site discharge, Incorrect dose administered by device, Device malfunction, |
||||
FREMANEZUMAB-VFRM, |
||||
| 145 | 26522420 |
US |
||
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 146 | 26522471 |
US |
||
Product dose omission issue, Device malfunction, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 147 | 26522476 |
US |
63 | 2 |
Asthma, Device malfunction, Device delivery system issue, Incorrect dose administered, |
||||
BECLOMETHASONE DIPROPIONATE, |
||||
| 148 | 26521225 |
US |
||
No adverse event, Device malfunction, No adverse event, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 149 | 26521227 |
US |
||
No adverse event, Device malfunction, No adverse event, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 150 | 26521277 |
US |
||
No adverse event, Device malfunction, No adverse event, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 151 | 26521279 |
US |
||
Device malfunction, Device malfunction, No adverse event, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 152 | 26521280 |
US |
||
No adverse event, Device malfunction, No adverse event, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 153 | 26521284 |
US |
||
No adverse event, Device malfunction, No adverse event, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 154 | 26521287 |
US |
||
No adverse event, Device malfunction, No adverse event, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 155 | 26521339 |
US |
69 | 2 |
Device malfunction, Product dose omission issue, Device malfunction, Product dose omission issue, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 156 | 26521340 |
US |
1 | |
Device malfunction, No adverse event, Device malfunction, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 157 | 26521449 |
US |
2 | |
Device malfunction, No adverse event, Device malfunction, No adverse event, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 158 | 26521459 |
US |
||
No adverse event, Device malfunction, No adverse event, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 159 | 26521460 |
US |
||
No adverse event, Device malfunction, No adverse event, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 160 | 26521478 |
US |
||
No adverse event, Device malfunction, No adverse event, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 161 | 26521659 |
US |
||
No adverse event, Device malfunction, No adverse event, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 162 | 26521872 |
US |
72 | |
Drug dose omission by device, Wrong technique in product usage process, Device malfunction, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 163 | 26517368 |
US |
||
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 164 | 26517405 |
US |
20 | 1 |
Product dose omission issue, Product storage error, Device malfunction, |
||||
GUSELKUMAB, |
||||
| 165 | 26517479 |
62 | ||
Glycosylated haemoglobin increased, Device malfunction, |
||||
METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, |
||||
| 166 | 26517685 |
US |
63 | 2 |
Dizziness, Therapy non-responder, Device infusion issue, Device malfunction, |
||||
TREPROSTINIL, TREPROSTINIL, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATED, SODIUM CHLORIDE, SODIUM CHLORIDE TABLET, SODIUM CHLORIDE TABLETS, KETAMINE HYDROCHLORIDE, ERTUGLIFLOZIN, ERGOCALCIFEROL, CLONIDINE, KETOPROFEN, SPIRONOLACTONE, OXYGEN, 0XYGEN, LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE ANHYDROUS, GABAPENTIN, |
||||
| 167 | 26517773 |
US |
||
Device malfunction, No adverse event, Device malfunction, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 168 | 26517934 |
US |
5 | 1 |
Device malfunction, Product dose omission issue, No adverse event, |
||||
OMALIZUMAB, |
||||
| 169 | 26518180 |
EU |
70 | |
Pain, Device malfunction, |
||||
ZICONOTIDE ACETATE, MORPHINE, ROPIVACAINE HYDROCHLORIDE, |
||||
| 170 | 26518347 |
US |
2 | |
Device malfunction, |
||||
SUMATRIPTAN SUCCINATE, |
||||
| 171 | 26518349 |
US |
1 | |
Device malfunction, Device issue, |
||||
SUMATRIPTAN SUCCINATE, |
||||
| 172 | 26518350 |
US |
2 | |
Device malfunction, Device leakage, |
||||
SUMATRIPTAN SUCCINATE, |
||||
| 173 | 26518351 |
US |
2 | |
Device malfunction, |
||||
SUMATRIPTAN SUCCINATE, |
||||
| 174 | 26518359 |
US |
2 | |
Device malfunction, Product container seal issue, |
||||
SUMATRIPTAN SUCCINATE, |
||||
| 175 | 26518360 |
US |
1 | |
Device malfunction, |
||||
SUMATRIPTAN SUCCINATE, |
||||
| 176 | 26518362 |
US |
||
Device malfunction, Device issue, |
||||
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE, |
||||
| 177 | 26518365 |
US |
1 | |
Device malfunction, Device loosening, |
||||
SUMATRIPTAN SUCCINATE, |
||||
| 178 | 26518366 |
US |
2 | |
Device malfunction, |
||||
SUMATRIPTAN SUCCINATE, |
||||
| 179 | 26518367 |
US |
1 | |
Device malfunction, |
||||
SUMATRIPTAN SUCCINATE, |
||||
| 180 | 26518369 |
US |
1 | |
Device malfunction, |
||||
SUMATRIPTAN SUCCINATE, |
||||
| 181 | 26518370 |
US |
1 | |
Device malfunction, |
||||
SUMATRIPTAN SUCCINATE, |
||||
| 182 | 26518373 |
US |
2 | |
Device malfunction, |
||||
SUMATRIPTAN SUCCINATE, |
||||
| 183 | 26518413 |
US |
2 | |
Device defective, Device malfunction, |
||||
SUMATRIPTAN SUCCINATE, |
||||
| 184 | 26518414 |
US |
2 | |
Device malfunction, |
||||
SUMATRIPTAN SUCCINATE, |
||||
| 185 | 26518454 |
|||
Device malfunction, Product dose omission issue, Accidental exposure to product, |
||||
BIMEKIZUMAB, |
||||
| 186 | 26518481 |
US |
||
Device issue, Device malfunction, |
||||
ENOXAPARIN SODIUM, |
||||
| 187 | 26518483 |
US |
1 | |
Device malfunction, |
||||
SUMATRIPTAN SUCCINATE, |
||||
| 188 | 26518484 |
US |
2 | |
Device malfunction, Device failure, |
||||
SUMATRIPTAN SUCCINATE, |
||||
| 189 | 26518485 |
US |
2 | |
Device malfunction, |
||||
SUMATRIPTAN SUCCINATE, |
||||
| 190 | 26518486 |
US |
2 | |
Device malfunction, Device mechanical issue, |
||||
SUMATRIPTAN SUCCINATE, |
||||
| 191 | 26518490 |
US |
||
Device issue, Device malfunction, |
||||
SUMATRIPTAN SUCCINATE, |
||||
| 192 | 26518491 |
US |
||
Device defective, Device malfunction, |
||||
SUMATRIPTAN SUCCINATE, |
||||
| 193 | 26518492 |
US |
1 | |
Device malfunction, |
||||
SUMATRIPTAN SUCCINATE, |
||||
| 194 | 26518494 |
US |
1 | |
Device malfunction, Device loosening, Device leakage, |
||||
SUMATRIPTAN SUCCINATE, |
||||
| 195 | 26518495 |
US |
2 | |
Device issue, Device malfunction, |
||||
SUMATRIPTAN SUCCINATE, |
||||
| 196 | 26518497 |
US |
2 | |
Device malfunction, |
||||
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE, |
||||
| 197 | 26518565 |
US |
2 | |
Device malfunction, |
||||
SUMATRIPTAN SUCCINATE, |
||||
| 198 | 26518566 |
US |
1 | |
Device malfunction, |
||||
SUMATRIPTAN SUCCINATE, |
||||
| 199 | 26518570 |
US |
2 | |
Device malfunction, |
||||
SUMATRIPTAN SUCCINATE, |
||||
| 200 | 26518572 |
US |
2 | |
Device malfunction, |
||||
SUMATRIPTAN SUCCINATE, |
||||
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