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 | 26541864 |
GB |
1 | |
Lower respiratory tract infection, Device issue, Unresponsive to stimuli, Sepsis, Pneumonia, |
||||
| 102 | 26541920 |
CA |
2 | |
Device issue, |
||||
GOLIMUMAB, |
||||
| 103 | 26531265 |
US |
62 | 2 |
Crohn^s disease, Device issue, Injection site haemorrhage, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 104 | 26531426 |
US |
2 | |
Device issue, General physical health deterioration, Device malfunction, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 105 | 26531529 |
US |
66 | 2 |
Injection site erythema, Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 106 | 26531888 |
US |
42 | 1 |
Pneumonia, Drug ineffective, Nasopharyngitis, Investigation abnormal, Pyrexia, Cough, Nasopharyngitis, Candida infection, Weight decreased, Cough, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, AMLODIPINE BESYLATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE, GLIPIZIDE, MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE, ESCITALOPRAM, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, HYDROCHLOROTHIAZIDE, RAMELTEON, DICLOFENAC SODIUM, LEVETIRACETAM, INSULIN LISPRO, DOXEPIN, DOXEPIN HYDROCHLORIDE, METOPROLOL TARTRATE, METOPROLOL, INSULIN GLARGINE, EMPAGLIFLOZIN, ERGOCALCIFEROL, |
||||
| 107 | 26531894 |
US |
||
Pain, Crohn^s disease, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 108 | 26532045 |
51 | ||
Device issue, Product dose omission issue, Off label use, |
||||
BIMEKIZUMAB, |
||||
| 109 | 26532173 |
US |
||
Drug dose omission by device, Device issue, Wrong technique in device usage process, No adverse event, |
||||
RISPERIDONE, |
||||
| 110 | 26532632 |
EU |
||
Product dose omission issue, Device issue, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 111 | 26532659 |
US |
2 | |
Cough, Device delivery system issue, Device information output issue, Device issue, |
||||
ALBUTEROL SULFATE, |
||||
| 112 | 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, |
||||
| 113 | 26533883 |
US |
1 | |
Injection site haemorrhage, Injection site pain, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 114 | 26533997 |
EU |
2 | |
Device issue, |
||||
SOMATROPIN, |
||||
| 115 | 26534166 |
US |
1 | |
Product dose omission issue, Off label use, Device issue, Accidental exposure to product, No adverse event, |
||||
OMALIZUMAB, OMALIZUMAB, |
||||
| 116 | 26534690 |
US |
2 | |
Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 117 | 26534838 |
US |
73 | 1 |
Blood glucose increased, Device issue, Intentional product use issue, Drug ineffective, |
||||
INSULIN GLARGINE-YFGN, INSULIN GLARGINE, INSULIN GLARGINE-YFGN, INSULIN GLARGINE, |
||||
| 118 | 26534930 |
US |
33 | 2 |
Device issue, Product dose omission issue, |
||||
ESKETAMINE HYDROCHLORIDE, |
||||
| 119 | 26534959 |
|||
Product dose omission issue, Device issue, |
||||
BIMEKIZUMAB, |
||||
| 120 | 26535297 |
US |
2 | |
Inflammation, Hypoaesthesia, Device issue, Product storage error, |
||||
ADALIMUMAB, |
||||
| 121 | 26535326 |
MX |
2 | |
Device issue, Inappropriate schedule of product administration, Product storage error, |
||||
GOLIMUMAB, |
||||
| 122 | 26535388 |
EU |
||
Device issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 123 | 26535625 |
US |
2 | |
Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 124 | 26527057 |
EU |
1 | |
Product dose omission issue, Product use issue, Device issue, Liquid product physical issue, |
||||
TEZEPELUMAB-EKKO, TEZEPELUMAB-EKKO, |
||||
| 125 | 26527146 |
US |
72 | |
Vocal cord disorder, Product preparation error, Device issue, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 126 | 26527471 |
|||
Accidental exposure to product, Device issue, Product dose omission issue, |
||||
BIMEKIZUMAB, |
||||
| 127 | 26527765 |
43 | ||
Device issue, Accidental exposure to product, Incorrect dose administered, |
||||
BIMEKIZUMAB, BIMEKIZUMAB, |
||||
| 128 | 26528210 |
US |
66 | 2 |
Immunodeficiency, Device issue, Product dose omission issue, Device defective, |
||||
ABATACEPT, ABATACEPT, VITAMIN C, PHYTONADIONE, |
||||
| 129 | 26528321 |
AR |
14 | 1 |
Insulin-like growth factor increased, Blood test abnormal, Needle fatigue, Incorrect dose administered by device, Device issue, |
||||
| 130 | 26528336 |
US |
58 | 2 |
Off label use, Device issue, |
||||
ABATACEPT, |
||||
| 131 | 26528536 |
US |
15 | 1 |
Device issue, No adverse event, Product dose omission issue, |
||||
OMALIZUMAB, OMALIZUMAB, |
||||
| 132 | 26528597 |
US |
73 | 2 |
Brain fog, Swollen tongue, Dyskinesia, Lip swelling, Ear pruritus, Throat irritation, Ear pain, Tremor, Tongue thrust, Increased upper airway secretion, Salivary hypersecretion, Confusional state, Hypertension, Dysarthria, Device issue, Head discomfort, Tongue pruritus, Tardive dyskinesia, Paranasal sinus hypersecretion, Failure to thrive, Dysphagia, |
||||
FOSCARBIDOPA/FOSLEVODOPA, FOSCARBIDOPA/FOSLEVODOPA, |
||||
| 133 | 26528650 |
EU |
52 | 1 |
Pneumothorax, Visual impairment, Restlessness, Gastrointestinal pain, Nocturia, Balance disorder, Loss of personal independence in daily activities, Aphasia, Parkinsonian gait, Restlessness, Pollakiuria, Parkinsonian gait, Dyschezia, Memory impairment, Device use issue, Gastrointestinal stoma complication, Dystonia, Muscle spasms, Weight decreased, Abnormal dreams, Insomnia, Stoma site discharge, Stoma site discharge, Dyskinesia, Therapeutic product effect incomplete, Dizziness, Orthostatic hypotension, Dizziness, Insomnia, Abnormal dreams, Stoma site discharge, Dyskinesia, Stoma site inflammation, Hyperkinesia, Middle insomnia, Bradykinesia, Unevaluable event, Hallucination, Medical device site scab, Hallucination, visual, Stoma site erythema, Stoma site irritation, Fall, Musculoskeletal chest pain, Unevaluable event, Peroneal nerve palsy, Muscle rigidity, Psychomotor hyperactivity, Head discomfort, Device breakage, Gait disturbance, Stoma site discharge, Somnolence, Poor quality sleep, Hunger, Brain fog, Device issue, Micturition urgency, Device power source issue, Device issue, Device connection issue, Fall, Pain, Mobility decreased, |
||||
| 134 | 26528904 |
MA |
2 | |
Device issue, Incorrect dose administered, |
||||
GOLIMUMAB, |
||||
| 135 | 26529454 |
US |
21 | 1 |
Surgery, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 136 | 26529524 |
EU |
73 | 1 |
Pneumonia, Decubitus ulcer, Contraindicated product administered, Secretion discharge, Hypokinesia, Asthenia, Nasopharyngitis, Akinesia, Psychomotor hyperactivity, Dyskinesia, Psychomotor hyperactivity, Weight decreased, Dysarthria, Nosocomial infection, Hyperkinesia, Somnolence, General physical health deterioration, Underdose, Incorrect dose administered, Device use error, Device issue, |
||||
CLINDAMYCIN HYDROCHLORIDE, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, AMANTADINE, AMLODIPINE, BISOPROLOL FUMARATE, CANDESARTAN, DARIFENACIN HYDROBROMIDE, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS, MAGNESIUM, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, MIRTAZAPINE, ROTIGOTINE, OXAZEPAM, OXYCODONE HYDROCHLORIDE, OXYCODONE, OXYCODONE, PANTOPRAZOLE, PREGABALIN, SERTRALINE, SIMVASTATIN, TAMSULOSIN HYDROCHLORIDE, |
||||
| 137 | 26529671 |
CA |
66 | 2 |
Device issue, Product dose omission issue, |
||||
GOLIMUMAB, |
||||
| 138 | 26529733 |
US |
31 | 2 |
Injection site erythema, Injection site irritation, Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 139 | 26530479 |
CO |
2 | |
Drug dose omission by device, Device mechanical issue, Device issue, |
||||
SOMATROPIN, |
||||
| 140 | 26530577 |
EU |
77 | 2 |
Akinesia, Device issue, Incorrect dose administered, Skin mass, |
||||
FOSCARBIDOPA/FOSLEVODOPA, PRAMIPEXOLE, |
||||
| 141 | 26530806 |
US |
68 | 2 |
Osteoporosis, Injection site urticaria, Injection site haemorrhage, Device issue, Injection site urticaria, Injection site haemorrhage, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, FISH OIL, ERGOCALCIFEROL, MESALAMINE, MESALAMINE, |
||||
| 142 | 26530925 |
US |
2 | |
Crohn^s disease, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 143 | 26530947 |
EG |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 144 | 26522646 |
US |
2 | |
Psoriasis, Drug ineffective, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 145 | 26522668 |
US |
2 | |
Injection site mass, Device issue, |
||||
FREMANEZUMAB-VFRM, FREMANEZUMAB-VFRM, |
||||
| 146 | 26522770 |
US |
2 | |
Injection site papule, Device issue, |
||||
ADALIMUMAB, |
||||
| 147 | 26522822 |
43 | ||
Injection site pain, Product dose omission issue, Device issue, Accidental exposure to product, |
||||
BIMEKIZUMAB, BIMEKIZUMAB, BIMEKIZUMAB, |
||||
| 148 | 26522869 |
AU |
2 | |
Arthralgia, Balance disorder, Gait disturbance, Injection site pain, Pain, Pain in extremity, Paraesthesia, Device issue, Diarrhoea, Nausea, |
||||
COLCHICINE, ETANERCEPT, |
||||
| 149 | 26522873 |
US |
65 | 1 |
Visual impairment, Device issue, Incorrect dose administered by device, Device malfunction, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 150 | 26522881 |
48 | ||
Device issue, Accidental exposure to product, |
||||
BIMEKIZUMAB, |
||||
| 151 | 26522893 |
29 | ||
Acne, Psoriasis, Drug ineffective, Product dose omission issue, Device issue, |
||||
BIMEKIZUMAB, BIMEKIZUMAB, |
||||
| 152 | 26523701 |
|||
Hidradenitis, Condition aggravated, Device issue, Product dose omission issue, |
||||
BIMEKIZUMAB, |
||||
| 153 | 26524633 |
US |
2 | |
Injection site bruising, Device issue, |
||||
ADALIMUMAB, |
||||
| 154 | 26524978 |
CO |
1 | |
Device issue, |
||||
SOMATROPIN, |
||||
| 155 | 26524989 |
US |
1 | |
Product dose omission issue, Device issue, |
||||
GUSELKUMAB, |
||||
| 156 | 26525417 |
AU |
||
Device issue, Device deployment issue, Product dose omission issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 157 | 26525600 |
US |
45 | 1 |
Needle issue, Device issue, Drug dose omission by device, Device operational issue, Device leakage, Accidental exposure to product, |
||||
SECUKINUMAB, SECUKINUMAB, |
||||
| 158 | 26525664 |
US |
2 | |
Product dose omission issue, Device issue, No adverse event, |
||||
TOCILIZUMAB, |
||||
| 159 | 26525720 |
US |
1 | |
Injection site papule, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 160 | 26525935 |
CN |
67 | 2 |
Syncope, Blood glucose increased, Device delivery system issue, Device issue, Drug diversion, |
||||
INSULIN ASPART, INSULIN ASPART, INSULIN ASPART, |
||||
| 161 | 26526459 |
US |
1 | |
Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 162 | 26526509 |
US |
1 | |
Injection site nodule, Fatigue, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 163 | 26526591 |
US |
2 | |
Crohn^s disease, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 164 | 26522017 |
US |
2 | |
Blood glucose increased, Device issue, |
||||
INSULIN GLARGINE, |
||||
| 165 | 26521769 |
US |
81 | 2 |
Blood glucose increased, Device issue, Stress, |
||||
INSULIN GLARGINE, INSULIN LISPRO, |
||||
| 166 | 26521925 |
US |
68 | 2 |
Blood glucose increased, Visual impairment, Eye operation, Device issue, |
||||
INSULIN GLARGINE, INSULIN DEGLUDEC, INSULIN DETEMIR, |
||||
| 167 | 26516874 |
US |
2 | |
Panic attack, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 168 | 26516907 |
GB |
32 | 1 |
Intestinal obstruction, Injection site mass, Device issue, Wrong technique in product usage process, Crohn^s disease, |
||||
RISANKIZUMAB-RZAA, |
||||
| 169 | 26516996 |
US |
56 | 2 |
Device issue, Device leakage, Incorrect dose administered by device, |
||||
SECUKINUMAB, FAMOTIDINE, |
||||
| 170 | 26517108 |
AR |
||
Device issue, |
||||
GOLIMUMAB, GOLIMUMAB, |
||||
| 171 | 26517174 |
US |
1 | |
Colour blindness, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 172 | 26517352 |
US |
1 | |
Injection site reaction, Device issue, Pain, Injection site haemorrhage, Injection site bruising, |
||||
ADALIMUMAB, |
||||
| 173 | 26517369 |
66 | ||
Blood glucose increased, Device issue, Device delivery system issue, Device mechanical issue, |
||||
| 174 | 26517411 |
CA |
78 | |
Lacrimation increased, Abdominal pain upper, Abdominal discomfort, Device issue, Incorrect dose administered by device, Intentional dose omission, Intentional product use issue, Product dispensing error, |
||||
OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, RABEPRAZOLE, ROSUVASTATIN, HYDROCHLOROTHIAZIDE, DULOXETINE HYDROCHLORIDE, DULOXETINE, AMLODIPINE, RAMIPRIL, PREGABALIN, LEFLUNOMIDE, FOLIC ACID, CETIRIZINE, CETIRIZINE HYDROCHLORIDE, CETIIRIZINE, |
||||
| 175 | 26517414 |
US |
2 | |
Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 176 | 26517472 |
68 | ||
Haemoglobin decreased, Device breakage, Device issue, |
||||
METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, |
||||
| 177 | 26517511 |
58 | ||
Blood glucose decreased, Device leakage, Device issue, |
||||
INSULIN ASPART, |
||||
| 178 | 26517726 |
EU |
||
Device issue, Product dose omission issue, |
||||
GOLIMUMAB, |
||||
| 179 | 26517903 |
US |
44 | 2 |
Exposure via skin contact, Device issue, No adverse event, |
||||
OMALIZUMAB, |
||||
| 180 | 26518037 |
US |
71 | 1 |
Visual impairment, Eye haemorrhage, Thrombosis, Retinal vein occlusion, Device issue, |
||||
FOSCARBIDOPA/FOSLEVODOPA, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATED, MIDODRINE HYDROCHLORIDE, QUETIAPINE FUMARATE, QUETIAPINE, SODIUM CHLORIDE, SODIUM CHLORIDE TABLET, SODIUM CHLORIDE TABLETS, CARBIDOPA AND LEVODOPA, |
||||
| 181 | 26518114 |
CH |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 182 | 26518349 |
US |
1 | |
Device malfunction, Device issue, |
||||
SUMATRIPTAN SUCCINATE, |
||||
| 183 | 26518362 |
US |
||
Device malfunction, Device issue, |
||||
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE, |
||||
| 184 | 26518372 |
US |
2 | |
Device issue, Device loosening, |
||||
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE, |
||||
| 185 | 26518375 |
US |
2 | |
Device issue, Product packaging quantity issue, |
||||
SUMATRIPTAN SUCCINATE, |
||||
| 186 | 26518481 |
US |
||
Device issue, Device malfunction, |
||||
ENOXAPARIN SODIUM, |
||||
| 187 | 26518489 |
US |
1 | |
Device issue, |
||||
SUMATRIPTAN SUCCINATE, |
||||
| 188 | 26518490 |
US |
||
Device issue, Device malfunction, |
||||
SUMATRIPTAN SUCCINATE, |
||||
| 189 | 26518495 |
US |
2 | |
Device issue, Device malfunction, |
||||
SUMATRIPTAN SUCCINATE, |
||||
| 190 | 26518562 |
US |
2 | |
Device issue, |
||||
SUMATRIPTAN SUCCINATE, |
||||
| 191 | 26518569 |
US |
2 | |
Device issue, |
||||
SUMATRIPTAN SUCCINATE, |
||||
| 192 | 26518588 |
US |
2 | |
Device issue, |
||||
SUMATRIPTAN SUCCINATE, |
||||
| 193 | 26518909 |
US |
||
Fall, Device issue, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 194 | 26519323 |
US |
86 | 2 |
Device issue, No adverse event, |
||||
RANIBIZUMAB, RANIBIZUMAB, RANIBIZUMAB, RANIBIZUMAB, RANIBIZUMAB, |
||||
| 195 | 26519806 |
US |
22 | 1 |
Device use error, Device issue, |
||||
SOMATROPIN, |
||||
| 196 | 26519816 |
CO |
1 | |
Drug dose omission by device, Device issue, |
||||
SOMATROPIN, |
||||
| 197 | 26519824 |
US |
13 | 2 |
Device issue, |
||||
SOMATROPIN, |
||||
| 198 | 26519903 |
US |
||
Device issue, |
||||
| 199 | 26519922 |
GB |
1 | |
Urinary retention, Feeling hot, Gait inability, Malaise, Feeling cold, Condition aggravated, Hyperhidrosis, Disorientation, Product ineffective, Device issue, |
||||
| 200 | 26520461 |
EU |
73 | 2 |
Device operational issue, Device issue, |
||||
FILGRASTIM, |
||||
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