Drug:
Reaction: DEVICE ISSUE
20250101 - 20251231
No. 101 - 200
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 101 | 25117195 |
IN |
||
Device issue, Product dose omission issue, |
||||
GOLIMUMAB, |
||||
| 102 | 25117275 |
IN |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 103 | 25117307 |
US |
79 | 1 |
Wrong technique in product usage process, Device issue, Injection site papule, Injection site swelling, Injection site erythema, |
||||
ADALIMUMAB, EMPAGLIFLOZIN, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, METOPROLOL TARTRATE, METOPROLOL, |
||||
| 104 | 25117336 |
DE |
40 | 2 |
Gallbladder disorder, Liver function test increased, Incorrect dose administered by device, Device issue, |
||||
INTERFERON BETA-1A, INTERFERON BETA-1A, |
||||
| 105 | 25117410 |
US |
||
Ligament sprain, Device issue, |
||||
ADALIMUMAB, |
||||
| 106 | 25117446 |
US |
35 | 2 |
Oedema peripheral, Device issue, Device leakage, |
||||
FREMANEZUMAB-VFRM, |
||||
| 107 | 25117676 |
US |
72 | 1 |
Device issue, Diarrhoea, Pain, Device issue, Drug ineffective, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 108 | 25117790 |
US |
38 | 2 |
Pain, Swelling, Condition aggravated, Device issue, |
||||
ADALIMUMAB, |
||||
| 109 | 25117792 |
US |
||
Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, |
||||
| 110 | 25118133 |
US |
2 | |
Device issue, Psoriasis, |
||||
RISANKIZUMAB-RZAA, |
||||
| 111 | 25118136 |
US |
||
Wrong technique in product usage process, Device issue, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 112 | 25118156 |
JP |
||
Device issue, |
||||
| 113 | 25118517 |
US |
23 | 1 |
Device issue, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
| 114 | 25118844 |
US |
38 | 2 |
Device issue, Product dose omission issue, |
||||
USTEKINUMAB, USTEKINUMAB, TIZANIDINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE, ESCITALOPRAM, PREGABALIN, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, |
||||
| 115 | 25119856 |
US |
13 | 1 |
Device issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 116 | 25119894 |
US |
62 | 2 |
Nervousness, Device use error, Device issue, |
||||
ADALIMUMAB, |
||||
| 117 | 25120125 |
US |
2 | |
Drug dose omission by device, Device issue, Device leakage, Accidental exposure to product, |
||||
SECUKINUMAB, |
||||
| 118 | 25120265 |
BR |
||
Device issue, |
||||
PEGFILGRASTIM, |
||||
| 119 | 25120410 |
MX |
46 | 2 |
Device issue, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
| 120 | 25120641 |
US |
19 | 1 |
Injection site swelling, Device issue, |
||||
RISANKIZUMAB-RZAA, |
||||
| 121 | 25120730 |
US |
57 | 1 |
Device issue, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
| 122 | 25120796 |
BR |
1 | |
Device issue, Product dose omission issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 123 | 25120862 |
CA |
44 | 2 |
Labyrinthitis, Crohn^s disease, Pyrexia, Influenza, Vomiting, Gait inability, Device issue, Nystagmus, |
||||
RISANKIZUMAB-RZAA, |
||||
| 124 | 25109993 |
US |
75 | 2 |
Drug delivery system malfunction, Wrong technique in product usage process, No adverse event, Device issue, |
||||
TOCILIZUMAB, TOCILIZUMAB, |
||||
| 125 | 25110148 |
US |
1 | |
Wrong technique in device usage process, Device issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 126 | 25110275 |
US |
12 | 1 |
No adverse event, Product dose omission issue, Needle issue, Device issue, |
||||
OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, METHYLPHENIDATE HYDROCHLORIDE, |
||||
| 127 | 25110300 |
US |
59 | 2 |
Haemorrhage, Limb injury, Device issue, Therapy interrupted, |
||||
BENRALIZUMAB, |
||||
| 128 | 25110597 |
US |
49 | 1 |
Abscess, Device issue, |
||||
RISANKIZUMAB-RZAA, |
||||
| 129 | 25110891 |
US |
||
Device issue, Drug ineffective, |
||||
ONABOTULINUMTOXINA, |
||||
| 130 | 25110941 |
US |
||
Device issue, |
||||
ESKETAMINE HYDROCHLORIDE, |
||||
| 131 | 25111445 |
US |
2 | |
Muscle spasms, Device difficult to use, Device issue, |
||||
GLATIRAMER ACETATE, |
||||
| 132 | 25111497 |
US |
60 | 2 |
Malaise, Injection site haemorrhage, Colitis ulcerative, Device issue, |
||||
ADALIMUMAB, METHOTREXATE, METHOTREXATE SODIUM, FOLIC ACID, LEVOTHYROXINE, |
||||
| 133 | 25111501 |
US |
71 | 2 |
Loss of consciousness, Dehydration, Device issue, Dizziness, Blood pressure fluctuation, |
||||
CARBIDOPA AND LEVODOPA, CARBIDOPA AND LEVODOPA, MELATONIN, QUETIAPINE FUMARATE, QUETIAPINE, TERBINAFINE HYDROCHLORIDE, TERBINAFINE, MIRABEGRON, CELECOXIB, RIVASTIGMINE, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATED, LEVOCETIRIZINE DIHYDROCHLORIDE, ERGOCALCIFEROL, UREA, CREAM, UREA, CREAM, DICLOFENAC SODIUM, |
||||
| 134 | 25111602 |
US |
||
Dysphonia, Device issue, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 135 | 25112198 |
US |
58 | 1 |
Wrong technique in product usage process, Arthralgia, Device issue, Injection site pain, |
||||
ADALIMUMAB, |
||||
| 136 | 25112208 |
GR |
14 | 1 |
Device issue, Poor quality device used, |
||||
SOMATROPIN, |
||||
| 137 | 25112274 |
US |
14 | 1 |
Device issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 138 | 25112279 |
US |
7 | 2 |
Device issue, Device use error, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 139 | 25112327 |
US |
12 | 1 |
Drug dose omission by device, Device difficult to use, Device issue, Device physical property issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 140 | 25112572 |
US |
2 | |
Incorrect dose administered, Device issue, Product dose omission issue, |
||||
BIMEKIZUMAB, BIMEKIZUMAB, |
||||
| 141 | 25112603 |
US |
2 | |
Incorrect dose administered, Device issue, |
||||
BIMEKIZUMAB, |
||||
| 142 | 25112628 |
US |
2 | |
Incorrect dose administered, Device issue, |
||||
BIMEKIZUMAB, |
||||
| 143 | 25112683 |
US |
42 | 2 |
Injection site pain, Inappropriate schedule of product administration, Device issue, |
||||
BIMEKIZUMAB, |
||||
| 144 | 25112684 |
US |
1 | |
Product dose omission issue, Device issue, |
||||
BIMEKIZUMAB, |
||||
| 145 | 25112768 |
US |
2 | |
Injection site bruising, Injection site pain, Device issue, Incorrect dose administered, Product dose omission issue, |
||||
BIMEKIZUMAB, BIMEKIZUMAB, BIMEKIZUMAB, BIMEKIZUMAB, |
||||
| 146 | 25112822 |
US |
48 | 2 |
Device issue, Accidental exposure to product, |
||||
BIMEKIZUMAB, BIMEKIZUMAB, |
||||
| 147 | 25112917 |
US |
1 | |
Inappropriate schedule of product administration, Device issue, Product dose omission issue, Product quality issue, |
||||
BIMEKIZUMAB, |
||||
| 148 | 25112958 |
US |
2 | |
Device issue, Incorrect dose administered, |
||||
BIMEKIZUMAB, |
||||
| 149 | 25112959 |
US |
2 | |
Product dispensing issue, Device issue, Incorrect dose administered, |
||||
BIMEKIZUMAB, |
||||
| 150 | 25113026 |
US |
1 | |
Weight increased, Fatigue, Device issue, |
||||
BIMEKIZUMAB, BIMEKIZUMAB, |
||||
| 151 | 25113286 |
US |
2 | |
Incorrect dose administered, Device issue, |
||||
BIMEKIZUMAB, |
||||
| 152 | 25113290 |
US |
2 | |
Product availability issue, Device issue, Product leakage, Incorrect dose administered, |
||||
BIMEKIZUMAB, |
||||
| 153 | 25113310 |
US |
2 | |
Product dose omission issue, Device issue, Accidental exposure to product, |
||||
BIMEKIZUMAB, |
||||
| 154 | 25113312 |
US |
2 | |
Product dose omission issue, Device issue, |
||||
BIMEKIZUMAB, |
||||
| 155 | 25113314 |
US |
1 | |
Device issue, Incorrect dose administered, |
||||
BIMEKIZUMAB, |
||||
| 156 | 25113319 |
US |
56 | 1 |
Device issue, Incorrect dose administered, Product dose omission issue, |
||||
BIMEKIZUMAB, BIMEKIZUMAB, |
||||
| 157 | 25113328 |
US |
2 | |
Incorrect dose administered, Device issue, Product dose omission issue, |
||||
BIMEKIZUMAB, BIMEKIZUMAB, BIMEKIZUMAB, SEMAGLUTIDE, INSULIN GLARGINE, CYCLOSPORINE, LISINOPRIL, EMPAGLIFLOZIN, ERGOCALCIFEROL, FISH OIL, HYDROCHLOROTHIAZIDE, GABAPENTIN, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS, SIMVASTATIN, METFORMIN HYDROCHLORIDE, METFORMIN, METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, METFORMIN HYDROCHLORIDE TABLET, METFORMIN HYDROCHLORIDE TABLETS, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, |
||||
| 158 | 25113463 |
US |
20 | |
Wrong technique in product usage process, Device issue, Accidental exposure to product, Product dose omission issue, Off label use, |
||||
PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE, |
||||
| 159 | 25113467 |
US |
2 | |
Mitral valve replacement, Abdominal pain upper, Device issue, Intestinal haemorrhage, Condition aggravated, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 160 | 25114096 |
US |
23 | 2 |
Product dose omission issue, Device defective, Device issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 161 | 25114134 |
FR |
||
Device issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 162 | 25114312 |
AR |
72 | 2 |
Device issue, Product dose omission issue, |
||||
GOLIMUMAB, |
||||
| 163 | 25114832 |
US |
42 | 2 |
Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 164 | 25115443 |
US |
60 | 2 |
Internal haemorrhage, Colitis ulcerative, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 165 | 25115519 |
US |
28 | 1 |
Incorrect dose administered by device, Wrong technique in device usage process, Device issue, Device leakage, |
||||
ADALIMUMAB-ADAZ, ADALIMUMAB-ADAZ, |
||||
| 166 | 25109165 |
US |
2 | |
Device difficult to use, Device issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 167 | 25109566 |
US |
||
Device issue, Injection site swelling, Injection site erythema, Injection site pain, |
||||
RISANKIZUMAB-RZAA, |
||||
| 168 | 25109629 |
US |
2 | |
Incorrect dose administered by device, Device issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 169 | 25109661 |
AU |
||
Device issue, Product dose omission issue, |
||||
GOLIMUMAB, |
||||
| 170 | 25109741 |
GB |
59 | 2 |
Device issue, Accidental exposure to product, Device deployment issue, |
||||
GOLIMUMAB, GOLIMUMAB, |
||||
| 171 | 25107847 |
US |
56 | 1 |
Psoriasis, Device issue, |
||||
RISANKIZUMAB-RZAA, |
||||
| 172 | 25107890 |
US |
85 | 2 |
Injection site reaction, Device issue, |
||||
ADALIMUMAB, |
||||
| 173 | 25107993 |
US |
84 | 2 |
Blood glucose increased, Device issue, |
||||
INSULIN GLARGINE, INSULIN ASPART, |
||||
| 174 | 25108391 |
US |
68 | 1 |
Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 175 | 25108602 |
US |
49 | 2 |
Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 176 | 25108633 |
US |
47 | 2 |
Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 177 | 25108671 |
US |
63 | |
Device issue, Drug dose omission by device, Wrong technique in product usage process, Off label use, Device deposit issue, No adverse event, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 178 | 25108927 |
US |
40 | 2 |
Infusion site pain, Infusion site pain, Device issue, |
||||
TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATED, LABETALOL HYDROCHLORIDE, LABETALOL, MELOXICAM, PAROXETINE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN, SODIUM CHLORIDE, SODIUM CHLORIDE INJECTION, SODIUM CHLORIDE TABLET, NORMAL SALT TABLETS, CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE, CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN, LISINOPRIL, ALBUTEROL SULFATE, CEFDINIR, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS, METOLAZONE, AMOXICILLIN AND CLAVULANATE POTASSIUM, IBUPROFEN, METOPROLOL SUCCINATE, METOPROLOL SUCCINATE ER TABLETS, BUMETANIDE, BUPROPION HYDROCHLORIDE, METFORMIN HYDROCHLORIDE, METFORMIN, METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, METFORMIN HYDROCHLORIDE TABLET, METFORMIN HYDROCHLORIDE TABLETS, NICOTINE, SPIRONOLACTONE, DOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MG, DOCUSATE SODIUM AND SENNOSIDES, DOCUSATE SODIUM, SENNOSIDES, DULOXETINE HYDROCHLORIDE, DULOXETIN HYDROCHLORIDE, DULOXETINE, FUROSEMIDE, AZITHROMYCIN, AZITHROMYCIN MONOHYDRATE, AZITHROMYCIN DIHYDRATE, CARVEDILOL, NAPROXEN, NAPROXEN SODIUM, ONDANSETRON HYDROCHLORIDE, BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE (XL), KETAMINE HYDROCHLORIDE, CLONIDINE, KETOPROFEN, LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE ANHYDROUS, AMITRIPTYLINE HYDROCHLORIDE, GABAPENTIN, |
||||
| 179 | 25102556 |
US |
42 | 2 |
Device issue, Accidental exposure to product, Injury associated with device, Drug dose omission by device, |
||||
OFATUMUMAB, |
||||
| 180 | 25102589 |
CA |
42 | |
Accident, Pneumonitis, Respiratory failure, Multiple fractures, Hyperhidrosis, Sensory loss, Device issue, Device use issue, Device delivery system issue, Wrong technique in device usage process, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 181 | 25102975 |
FR |
||
Device issue, |
||||
DARUNAVIR, DARUNAVIR, |
||||
| 182 | 25103101 |
US |
19 | 2 |
Stillbirth, Ovarian cyst, Device breakage, Foreign body in reproductive tract, Complication of device removal, Embedded device, Pregnancy with contraceptive device, Drug ineffective, Emotional disorder, Device issue, Device dislocation, Abnormal uterine bleeding, Abdominal pain, Device use issue, Off label use, |
||||
COPPER, |
||||
| 183 | 25103154 |
US |
||
Device issue, |
||||
NITRIC OXIDE, |
||||
| 184 | 25103294 |
US |
1 | |
Device issue, Product leakage, Accidental exposure to product, Product dose omission issue, |
||||
SECUKINUMAB, |
||||
| 185 | 25103793 |
US |
81 | 2 |
Surgery, Device issue, |
||||
ADALIMUMAB, |
||||
| 186 | 25103851 |
US |
77 | 1 |
Death, Pneumothorax, Pneumonia, Upper respiratory fungal infection, Dry throat, Choking sensation, Cough, Respiratory disorder, Blood pressure increased, Wrong technique in device usage process, Incorrect dose administered by device, Therapeutic product effect variable, Device difficult to use, Device issue, |
||||
LEVODOPA, LEVODOPA, CARBIDOPA AND LEVODOPA, CARBIDOPA AND LEVODOPA, |
||||
| 187 | 25104623 |
US |
22 | 2 |
Drug dose omission by device, Device issue, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, |
||||
| 188 | 25104868 |
US |
67 | 2 |
Death, Infusion site pain, Dyspnoea exertional, Fatigue, Hypotension, Breath sounds abnormal, Arthralgia, Device issue, Device leakage, Device physical property issue, |
||||
TREPROSTINIL, TREPROSTINIL, SODIUM CHLORIDE, SODIUM CHLORIDE INJECTION, SODIUM CHLORIDE TABLET, NORMAL SALT TABLETS, APIXABAN, LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE ANHYDROUS, MAGNESIUM, BUMETANIDE, GUAIFENESIN, PRUCALOPRIDE, POLYETHYLENE GLYCOL, BENZONATATE, POTASSIUM CHLORIDE, POTASSIUM CHLORIDE EXTENDED-RELEASE, POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE, POTASSIUM CHLORIDE ORAL, KETAMINE HYDROCHLORIDE, CLONIDINE, KETOPROFEN, GABAPENTIN, |
||||
| 189 | 25104904 |
US |
66 | 1 |
Wrong technique in device usage process, Device delivery system issue, Device mechanical issue, Device issue, Product container seal issue, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE, |
||||
| 190 | 25105124 |
US |
55 | 1 |
Off label use, Device delivery system issue, Device issue, Device malfunction, |
||||
FLUTICASONE PROPIONATE AND SALMETEROL, |
||||
| 191 | 25105275 |
US |
50 | 2 |
Device malfunction, Device issue, Accidental exposure to product, Product dose omission issue, Drug delivery system malfunction, Injury associated with device, |
||||
GUSELKUMAB, |
||||
| 192 | 25105698 |
US |
||
Device issue, Drug dose omission by device, |
||||
BUPRENORPHINE, |
||||
| 193 | 25105766 |
US |
||
Device issue, Product dose omission issue, |
||||
BUPRENORPHINE, |
||||
| 194 | 25105840 |
US |
||
Device issue, Inappropriate schedule of product administration, |
||||
BUPRENORPHINE, |
||||
| 195 | 25106123 |
CO |
8 | 1 |
Device issue, |
||||
SOMATROPIN, |
||||
| 196 | 25106152 |
CO |
15 | 1 |
Device issue, |
||||
SOMATROPIN, |
||||
| 197 | 25106322 |
US |
13 | 1 |
Drug dose omission by device, Device issue, Device mechanical issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 198 | 25106402 |
US |
58 | 2 |
Device issue, Inappropriate schedule of product administration, |
||||
GOLIMUMAB, |
||||
| 199 | 25106427 |
GB |
1 | |
Product temperature excursion issue, Product dose omission issue, Device issue, |
||||
GOLIMUMAB, |
||||
| 200 | 25106809 |
US |
2 | |
Device issue, |
||||
MEDROXYPROGESTERONE ACETATE, |
||||
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
2025-04-28