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 | 26922560 |
US |
||
Product dose omission issue, Ill-defined disorder, Injection site rash, Injection site swelling, Injection site pruritus, Device malfunction, |
||||
TOCILIZUMAB, |
||||
| 102 | 26922688 |
US |
||
No adverse event, Device malfunction, Device malfunction, No adverse event, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 103 | 26922745 |
US |
46 | 2 |
Product dose omission issue, Device malfunction, Product dose omission issue, Device malfunction, |
||||
PEGFILGRASTIM-CBQV, CARBOPLATIN, DOCETAXEL, DOCETAXEL ANHYDROUS, PERTUZUMAB, TRASTUZUMAB, AND HYALURONIDASE-ZZXF, |
||||
| 104 | 26922866 |
US |
||
Device malfunction, Device malfunction, No adverse event, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 105 | 26922962 |
US |
59 | 2 |
Device malfunction, Accidental exposure to product, Incorrect dose administered by device, |
||||
SECUKINUMAB, MONTELUKAST, LORATADINE, LORATADINE TABLET, NAPROXEN, NAPROXEN SODIUM, |
||||
| 106 | 26923082 |
US |
2 | |
Confusional state, Device delivery system issue, Device malfunction, Product dose omission issue, Incorrect dose administered by device, Device defective, Wrong technique in product usage process performed in error, Dyspnoea, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 107 | 26923230 |
US |
61 | 2 |
Injection site haemorrhage, Device malfunction, Device leakage, |
||||
| 108 | 26923271 |
US |
65 | 1 |
Device malfunction, Accidental exposure to product, Drug dose omission by device, |
||||
SECUKINUMAB, CARVEDILOL, |
||||
| 109 | 26923455 |
US |
63 | |
Dyspnoea, Drug dose omission by device, Device delivery system issue, Off label use, Device malfunction, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 110 | 26923582 |
US |
2 | |
Device malfunction, Overdose, Device use error, Product use issue, Malaise, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 111 | 26923607 |
US |
58 | 2 |
Malaise, Device malfunction, |
||||
PEGFILGRASTIM, |
||||
| 112 | 26923624 |
US |
||
Injury associated with device, Device malfunction, Off label use of device, |
||||
| 113 | 26923625 |
US |
||
Injury associated with device, Device malfunction, Off label use of device, |
||||
| 114 | 26923630 |
US |
1 | |
Device malfunction, |
||||
SUMATRIPTAN SUCCINATE, |
||||
| 115 | 26923776 |
US |
||
Illness, Device malfunction, Product quality issue, |
||||
| 116 | 26924155 |
US |
2 | |
Illness, Incorrect dose administered by device, Device malfunction, |
||||
| 117 | 26924316 |
EU |
1 | |
Delusion, Drug ineffective, Therapeutic response shortened, Device malfunction, |
||||
ARIPIPRAZOLE, ARIPIPRAZOLE, OXAZEPAM, |
||||
| 118 | 26924318 |
US |
1 | |
Seizure, Device malfunction, Product dose omission issue, |
||||
MIDAZOLAM, |
||||
| 119 | 26924618 |
US |
43 | 1 |
Device malfunction, Device leakage, Drug dose omission by device, |
||||
SECUKINUMAB, |
||||
| 120 | 26925077 |
US |
52 | 1 |
Dyspnoea, Product dose omission issue, Device malfunction, Wrong technique in product usage process, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 121 | 26925780 |
US |
70 | |
Dermatitis atopic, Device malfunction, Incorrect dose administered, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 122 | 26926230 |
US |
56 | 1 |
Increased appetite, Device malfunction, Drug ineffective, Incorrect dose administered by device, |
||||
| 123 | 26926529 |
US |
2 | |
Dyspnoea, Device malfunction, Needle issue, Device wireless communication issue, |
||||
TREPROSTINIL, |
||||
| 124 | 26914743 |
US |
53 | 2 |
Device malfunction, Needle issue, Device delivery system issue, Incorrect dose administered by device, |
||||
SECUKINUMAB, |
||||
| 125 | 26914923 |
US |
1 | |
Product dose omission issue, Device malfunction, Product use complaint, Device delivery system issue, |
||||
ALBUTEROL SULFATE, |
||||
| 126 | 26915005 |
US |
73 | |
Device malfunction, Incorrect dose administered, Injection site haemorrhage, |
||||
GUSELKUMAB, |
||||
| 127 | 26915046 |
CA |
2 | |
Device malfunction, Device leakage, |
||||
TIOTROPIUM BROMIDE INHALATION SPRAY, FLUTICASONE FUROATE AND VILANTEROL TRIFENATATE, |
||||
| 128 | 26915299 |
US |
2 | |
Visual impairment, Device malfunction, |
||||
ORAL SEMAGLUTIDE, |
||||
| 129 | 26915359 |
US |
63 | 2 |
Pulmonary hypertension, Dyspnoea, Product dose omission issue, Device malfunction, Device malfunction, |
||||
TREPROSTINIL, TREPROSTINIL, SOTATERCEPT-CSRK, PANTOPRAZOLE SODIUM, MIDODRINE HYDROCHLORIDE, IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE, LORATADINE, LORATADINE TABLET, ALBUTEROL SULFATE, IPRATROPIUM BROMIDE, MACITENTAN, FERROUS SULFATE, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, SUCRALFATE, SUCRALFATE ORAL SUSPENSION, SUCRALFATE ORAL, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATED, BUMETANIDE, PREDNISONE, OXYGEN, 0XYGEN, NAPROXEN SODIUM, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, GUAIFENESIN, NAPROXEN SODIUM, PSEUDOEPHEDRINE HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE, BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 130 | 26915570 |
US |
54 | 2 |
Visual impairment, Drug ineffective, Unevaluable event, Hunger, Device malfunction, |
||||
| 131 | 26915708 |
US |
||
Product dose omission issue, Device malfunction, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 132 | 26915802 |
US |
2 | |
Product dose omission issue, Device malfunction, Feeling abnormal, |
||||
| 133 | 26915813 |
US |
28 | |
Incorrect dose administered by device, Device delivery system issue, Device deposit issue, Wrong technique in product usage process, Device malfunction, No adverse event, |
||||
ALBUTEROL SULFATE, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, |
||||
| 134 | 26916082 |
US |
52 | |
Drug dose omission by device, Wrong technique in product usage process, Device deposit issue, Device malfunction, Device delivery system issue, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 135 | 26916119 |
US |
||
Device malfunction, |
||||
NITRIC OXIDE, NITRIC OXIDE, |
||||
| 136 | 26916136 |
US |
||
Device malfunction, |
||||
DICLOFENAC, DICLOFENAC SODIUM, |
||||
| 137 | 26916554 |
US |
||
Foreign body aspiration, Device malfunction, Device breakage, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 138 | 26916838 |
US |
57 | |
Accidental exposure to product, Device malfunction, Ocular hyperaemia, Eye pain, |
||||
| 139 | 26917330 |
US |
11 | 1 |
Device mechanical issue, Device malfunction, Device delivery system issue, Device issue, Product quality issue, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE, |
||||
| 140 | 26917479 |
US |
69 | |
Device malfunction, Incorrect dose administered, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 141 | 26917538 |
US |
35 | 2 |
Injection site haemorrhage, Device difficult to use, Device malfunction, |
||||
LIRAGLUTIDE, |
||||
| 142 | 26917566 |
GB |
76 | 1 |
Drug dose omission by device, Device malfunction, |
||||
SOMATROPIN, |
||||
| 143 | 26917599 |
US |
1 | |
Brain fog, Device leakage, Incorrect dose administered by device, Wrong technique in product usage process, Device malfunction, |
||||
ORAL SEMAGLUTIDE, ORAL SEMAGLUTIDE, ORAL SEMAGLUTIDE, |
||||
| 144 | 26917666 |
US |
2 | |
Injection site indentation, Device malfunction, Scar, Burning sensation, |
||||
| 145 | 26917860 |
US |
59 | 1 |
Headache, Rhinorrhoea, Ocular discomfort, Device malfunction, Blood pressure fluctuation, Device delivery system issue, |
||||
BECLOMETHASONE DIPROPIONATE HFA, |
||||
| 146 | 26918739 |
US |
2 | |
Dyspnoea, Product dose omission issue, Overdose, Incorrect dose administered by device, Device malfunction, Product communication issue, |
||||
| 147 | 26918804 |
JP |
1 | |
Device use error, Device malfunction, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 148 | 26919019 |
US |
2 | |
Skin pressure mark, Product leakage, Device malfunction, |
||||
| 149 | 26919861 |
US |
43 | 2 |
Incorrect dose administered by device, Weight loss poor, Weight increased, Device malfunction, Dry throat, |
||||
| 150 | 26919938 |
US |
67 | |
Injection site haemorrhage, Device malfunction, Product dose omission issue, Incorrect dose administered, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 151 | 26919989 |
US |
62 | |
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 152 | 26920275 |
US |
||
Acne, Drug effect less than expected, Product dose omission issue, Device malfunction, Intentional product use issue, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 153 | 26920298 |
US |
33 | |
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 154 | 26921152 |
US |
80 | |
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 155 | 26921181 |
US |
72 | 2 |
Spinal operation, Psychomotor hyperactivity, Nervousness, Psoriasis, Device malfunction, Product leakage, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
| 156 | 26909493 |
US |
2 | |
Blood glucose increased, Drug delivery system issue, Device malfunction, |
||||
INSULIN DEGLUDEC, |
||||
| 157 | 26909496 |
AR |
56 | 1 |
Device malfunction, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
| 158 | 26909571 |
US |
||
Device malfunction, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 159 | 26909576 |
US |
2 | |
Device malfunction, Accidental exposure to product, |
||||
GUSELKUMAB, |
||||
| 160 | 26909682 |
US |
1 | |
Drug dose omission by device, Product use complaint, Device failure, Device malfunction, No adverse event, |
||||
LIRAGLUTIDE, LIRAGLUTIDE, |
||||
| 161 | 26909840 |
US |
24 | 2 |
Device malfunction, Incorrect dose administered by device, Wrong technique in product usage process, |
||||
GUSELKUMAB, |
||||
| 162 | 26909948 |
US |
43 | 1 |
Product dose omission issue, Accidental exposure to product, Device malfunction, Needle issue, Product leakage, |
||||
GUSELKUMAB, GUSELKUMAB, |
||||
| 163 | 26910394 |
US |
53 | |
Product dose omission issue, Device malfunction, Product use in unapproved indication, |
||||
NEMOLIZUMAB-ILTO, DOXYCYCLINE, DOXYCYCLINE HYCLATE, |
||||
| 164 | 26910599 |
US |
2 | |
Device malfunction, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 165 | 26911144 |
US |
1 | |
No adverse event, Device malfunction, Device leakage, Product dose omission issue, |
||||
VEDOLIZUMAB, VEDOLIZUMAB, |
||||
| 166 | 26911721 |
US |
||
Wrong technique in device usage process, Device malfunction, Device breakage, Syringe issue, |
||||
PEGCETACOPLAN, |
||||
| 167 | 26912285 |
US |
2 | |
Blindness, Device malfunction, Product dose omission issue, |
||||
| 168 | 26912455 |
US |
2 | |
Increased appetite, Drug ineffective, Device malfunction, |
||||
| 169 | 26912585 |
GB |
2 | |
Drug dose omission by device, Device malfunction, |
||||
SOMATROPIN, |
||||
| 170 | 26912641 |
US |
6 | 2 |
Bowen^s disease, Squamous cell carcinoma of skin, Device malfunction, |
||||
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, MEROPENEM, PREDNISONE, FLUOROURACIL CREAM, 0.5%, FLUOROURACIL, |
||||
| 171 | 26913042 |
US |
||
Decreased appetite, Injection site discharge, Device malfunction, Injection site haemorrhage, |
||||
| 172 | 26913385 |
US |
||
Device malfunction, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, |
||||
| 173 | 26913582 |
US |
60 | 2 |
Incorrect dose administered by device, Device malfunction, Device leakage, Accidental exposure to product, Increased appetite, |
||||
| 174 | 26913633 |
US |
2 | |
Device malfunction, Sensory loss, Device leakage, |
||||
| 175 | 26913814 |
US |
70 | 1 |
Device malfunction, Needle issue, Incorrect dose administered by device, |
||||
SECUKINUMAB, CINNAMON, |
||||
| 176 | 26914221 |
US |
||
Wound, Device malfunction, |
||||
| 177 | 26904840 |
US |
76 | |
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 178 | 26904844 |
US |
64 | |
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 179 | 26904973 |
US |
||
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 180 | 26904981 |
US |
2 | |
Device malfunction, Device leakage, Food craving, Drug dose omission by device, Injection site discharge, |
||||
| 181 | 26905207 |
US |
65 | 1 |
Product dose omission issue, Device use error, Product delivery mechanism issue, Device malfunction, Product supply issue, |
||||
ALBUTEROL SULFATE AND BUDESONIDE, BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 182 | 26905436 |
CN |
||
Hospitalisation, Device malfunction, Device failure, |
||||
| 183 | 26905473 |
US |
1 | |
Blood glucose increased, Device malfunction, Drug ineffective, Hunger, Eructation, Flatulence, |
||||
ORAL SEMAGLUTIDE, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, |
||||
| 184 | 26905760 |
US |
||
Needle track marks, Inappropriate schedule of product administration, Device malfunction, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 185 | 26905915 |
US |
60 | |
Product dose omission issue, Device malfunction, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 186 | 26905946 |
US |
68 | 2 |
Pain, Device malfunction, Accidental overdose, Abdominal pain upper, |
||||
ORAL SEMAGLUTIDE, |
||||
| 187 | 26906199 |
US |
1 | |
Device defective, Device malfunction, Device delivery system issue, Incorrect dose administered by device, |
||||
SECUKINUMAB, |
||||
| 188 | 26906376 |
US |
64 | |
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 189 | 26906464 |
US |
33 | |
Product dose omission issue, Device malfunction, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 190 | 26906636 |
US |
44 | 2 |
Product dose omission issue, Device malfunction, Wrong technique in product usage process, Pain, |
||||
| 191 | 26906772 |
US |
2 | |
Dyspnoea, Device issue, Device delivery system issue, Device malfunction, |
||||
FLUTICASONE PROPIONATE AND SALMETEROL, FLUTICASONE PROPIONATE AND SALMETEROL, FLUTICASONE PROPIONATE AND SALMETEROL, FLUTICASONE PROPIONATE AND SALMETEROL, |
||||
| 192 | 26907155 |
US |
1 | |
Device malfunction, |
||||
MIDAZOLAM, |
||||
| 193 | 26907949 |
US |
64 | |
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 194 | 26908009 |
US |
||
Device malfunction, |
||||
PEGFILGRASTIM, |
||||
| 195 | 26908207 |
US |
1 | |
Product dose omission issue, Device defective, Device malfunction, Product quality issue, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 196 | 26908226 |
US |
73 | 2 |
Injection site pain, Device malfunction, Accidental exposure to product, Incorrect dose administered by device, |
||||
FREMANEZUMAB-VFRM, |
||||
| 197 | 26908271 |
US |
2 | |
Cough, Device malfunction, Insurance issue, Product delivery mechanism issue, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 198 | 26908799 |
US |
71 | 1 |
Device use issue, Product dose omission issue, Product cleaning inadequate, Device mechanical issue, Device difficult to use, Device delivery system issue, Device malfunction, |
||||
ALBUTEROL SULFATE AND BUDESONIDE, BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 199 | 26909150 |
US |
28 | 2 |
Drug dose omission by device, Device malfunction, Injection site discharge, Injection site haemorrhage, |
||||
| 200 | 26909152 |
US |
38 | 2 |
Injection site vesicles, Device malfunction, Drug dose omission by device, |
||||
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