Drug:
Reaction: DEVICE DELIVERY SYSTEM ISSUE
20250101 - 20251231
No. 1 - 100
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 1 | 25491795 |
US |
1 | |
Drug dose omission by device, Device delivery system issue, Product delivery mechanism issue, |
||||
ALBUTEROL SULFATE, |
||||
| 2 | 25492137 |
US |
2 | |
Drug dose omission by device, Device delivery system issue, Device use error, |
||||
ALBUTEROL SULFATE, |
||||
| 3 | 25492529 |
US |
||
Drug dose omission by device, Device deposit issue, Device delivery system issue, No adverse event, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 4 | 25492552 |
US |
||
Dyspnoea, Drug dose omission by device, Wrong technique in product usage process, Incorrect dose administered by device, Device issue, Device deposit issue, Device delivery system issue, |
||||
ALBUTEROL SULFATE, |
||||
| 5 | 25493004 |
US |
||
Incorrect dose administered by device, Device delivery system issue, No adverse event, |
||||
LEVALBUTEROL TARTRATE, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 6 | 25493012 |
US |
||
Drug dose omission by device, Device delivery system issue, No adverse event, |
||||
LEVALBUTEROL TARTRATE, |
||||
| 7 | 25493894 |
CO |
14 | 1 |
Device delivery system issue, |
||||
SOMATROPIN, |
||||
| 8 | 25494262 |
US |
||
Treatment noncompliance, Device delivery system issue, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 9 | 25495008 |
US |
55 | 2 |
Device use error, Device delivery system issue, |
||||
ESTRADIOL, ESTRADIOL GEL 0.1%, ESTRADIOL TRANSDERMAL, ESTRADIOL,, ESTRADIOL, ESTRADIOL GEL 0.1%, ESTRADIOL TRANSDERMAL, ESTRADIOL,, ESTRADIOL, ESTRADIOL GEL 0.1%, ESTRADIOL TRANSDERMAL, ESTRADIOL,, ESTRADIOL, ESTRADIOL GEL 0.1%, ESTRADIOL TRANSDERMAL, ESTRADIOL,, |
||||
| 10 | 25495519 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 11 | 25495960 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 12 | 25491336 |
US |
5 | 1 |
Incorrect drug administration rate, Device delivery system issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 13 | 25491455 |
US |
1 | |
Product dose omission issue, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 14 | 25491630 |
US |
26 | 2 |
Device operational issue, Device delivery system issue, Device safety feature issue, |
||||
ABATACEPT, |
||||
| 15 | 25490227 |
US |
||
Circumstance or information capable of leading to device use error, Device delivery system issue, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 16 | 25490229 |
US |
46 | |
Dyspnoea, Wheezing, Cough, Drug dose omission by device, Device delivery system issue, Wrong technique in product usage process, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, |
||||
| 17 | 25490318 |
US |
||
Chest discomfort, Drug dose omission by device, Device delivery system issue, Product identification number issue, |
||||
ALBUTEROL SULFATE, |
||||
| 18 | 25490641 |
US |
||
Drug dose omission by device, Device delivery system issue, No adverse event, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 19 | 25486424 |
US |
35 | 2 |
Incorrect dose administered by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, |
||||
| 20 | 25486815 |
US |
||
Drug dose omission by device, Device delivery system issue, Device issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 21 | 25487219 |
US |
81 | |
Off label use, Drug dose omission by device, Device deposit issue, Device malfunction, Expired product administered, Device issue, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 22 | 25487599 |
US |
||
Drug dose omission by device, Device delivery system issue, Device deposit issue, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 23 | 25487604 |
US |
||
Device delivery system issue, Wrong technique in device usage process, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 24 | 25488054 |
US |
||
Drug dose omission by device, Device delivery system issue, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 25 | 25488920 |
US |
||
Chest discomfort, Drug dose omission by device, Device delivery system issue, Device mechanical issue, |
||||
ALBUTEROL SULFATE, |
||||
| 26 | 25488993 |
CL |
16 | 1 |
Device leakage, Device delivery system issue, Incorrect dose administered by device, |
||||
SOMATROPIN, |
||||
| 27 | 25481420 |
US |
||
Drug dose omission by device, Device delivery system issue, Device malfunction, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, EPINEPHRINE INHALATION, |
||||
| 28 | 25481877 |
US |
||
Device issue, Device delivery system issue, |
||||
MEDROXYPROGESTERONE ACETATE, |
||||
| 29 | 25482194 |
US |
65 | |
Wrong technique in product usage process, Device delivery system issue, No adverse event, |
||||
ALBUTEROL SULFATE, QUETIAPINE, PANTOPRAZOLE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, |
||||
| 30 | 25482209 |
US |
39 | |
Wrong technique in product usage process, Device delivery system issue, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 31 | 25482226 |
US |
64 | |
Device delivery system issue, Wrong technique in product usage process, No adverse event, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 32 | 25482245 |
US |
41 | |
Drug dose omission by device, Device delivery system issue, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 33 | 25482582 |
US |
||
Asthma, Device delivery system issue, Drug dose omission by device, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 34 | 25482805 |
US |
65 | |
Drug dose omission by device, Device delivery system issue, Device deposit issue, Device malfunction, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 35 | 25482964 |
US |
||
Drug dose omission by device, Device delivery system issue, No adverse event, |
||||
LEVALBUTEROL TARTRATE, |
||||
| 36 | 25483137 |
US |
87 | 2 |
Product taste abnormal, Device delivery system issue, Device issue, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE, BUDESONIDE AND FORMOTEROL FUMARATE, BUDESONIDE AND FORMOTEROL FUMARATE, BUDESONIDE AND FORMOTEROL FUMARATE, BUDESONIDE AND FORMOTEROL FUMARATE, BUDESONIDE AND FORMOTEROL FUMARATE, BUDESONIDE AND FORMOTEROL FUMARATE, BUDESONIDE AND FORMOTEROL FUMARATE, AMLODIPINE, AMLODIPINE, AMLODIPINE, AMLODIPINE, METOPROLOL TARTRATE, METOPROLOL, METOPROLOL TARTRATE, METOPROLOL, METOPROLOL TARTRATE, METOPROLOL, METOPROLOL TARTRATE, METOPROLOL, RABEPRAZOLE, RABEPRAZOLE, RABEPRAZOLE, RABEPRAZOLE, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 37 | 25483321 |
US |
63 | |
Device delivery system issue, Wrong technique in product usage process, Device deposit issue, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 38 | 25483444 |
CL |
22 | 2 |
Device delivery system issue, Device physical property issue, Drug dose omission by device, |
||||
ETANERCEPT, |
||||
| 39 | 25483446 |
CO |
1 | |
Peripheral swelling, Wrong technique in device usage process, Device physical property issue, Device delivery system issue, |
||||
SOMATROPIN, |
||||
| 40 | 25484917 |
US |
||
Drug dose omission by device, Device delivery system issue, Device malfunction, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 41 | 25484918 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 42 | 25485176 |
US |
||
Circumstance or information capable of leading to medication error, Device delivery system issue, |
||||
ALBUTEROL SULFATE, |
||||
| 43 | 25485293 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 44 | 25485301 |
US |
||
Drug dose omission by device, Device delivery system issue, Device mechanical issue, Device malfunction, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 45 | 25485513 |
US |
||
Circumstance or information capable of leading to medication error, Device breakage, Device delivery system issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 46 | 25475909 |
US |
||
Dyspnoea, Incorrect dose administered by device, Wrong technique in device usage process, Device delivery system issue, Corrective lens user, |
||||
GLYCOPYRROLATE AND FORMOTEROL FUMARATE, |
||||
| 47 | 25476789 |
US |
||
Product dose omission issue, Intentional device use issue, Device delivery system issue, |
||||
ALBUTEROL SULFATE AND BUDESONIDE, |
||||
| 48 | 25476805 |
US |
||
Device use issue, Device delivery system issue, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 49 | 25476910 |
US |
||
Device delivery system issue, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 50 | 25477375 |
US |
61 | |
Drug dose omission by device, Device delivery system issue, No adverse event, Product storage error, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 51 | 25477378 |
US |
||
Lung neoplasm malignant, Cough, Dyspnoea, Product dose omission issue, Device delivery system issue, Device delivery system issue, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 52 | 25477820 |
US |
||
Drug dose omission by device, Device delivery system issue, Expired device used, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 53 | 25477881 |
US |
2 | |
Injection site pain, Device difficult to use, Device issue, Device delivery system issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 54 | 25477992 |
US |
25 | |
Dyspnoea, Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 55 | 25478994 |
US |
||
Product dose omission issue, Device delivery system issue, |
||||
ALBUTEROL SULFATE AND BUDESONIDE, |
||||
| 56 | 25480614 |
CO |
14 | 1 |
Device delivery system issue, Device physical property issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 57 | 25481037 |
US |
70 | |
Drug dose omission by device, Device delivery system issue, Device malfunction, Device deposit issue, No adverse event, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALLOPURINOL, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, HYDROCORTISONE, FOLIC ACID, FUROSEMIDE, UMECLIDINIUM, LATANOPROST, MAGNESIUM OXIDE, MELATONIN, METOLAZONE, METOPROLOL TARTRATE, METOROPROLOL TARTRATE, METOPROLOL, POTASSIUM CHLORIDE, POTASSIUM CHLORIDE EXTENDED-RELEASE, POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE, POTASSIUM CHLORIDE ORAL, |
||||
| 58 | 25481060 |
US |
82 | |
Drug dose omission by device, Device delivery system issue, No adverse event, |
||||
LEVALBUTEROL TARTRATE, |
||||
| 59 | 25470449 |
US |
56 | |
Swelling, Product dose omission issue, Device leakage, Device delivery system issue, |
||||
BENRALIZUMAB, |
||||
| 60 | 25470844 |
US |
||
Dizziness, Feeling abnormal, Device delivery system issue, Device use issue, |
||||
ALBUTEROL SULFATE AND BUDESONIDE, |
||||
| 61 | 25471050 |
US |
1 | |
Device delivery system issue, Device issue, Wrong technique in product usage process, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 62 | 25471192 |
US |
30 | |
Drug dose omission by device, Device delivery system issue, No adverse event, |
||||
LEVALBUTEROL TARTRATE, |
||||
| 63 | 25471317 |
US |
2 | |
Incorrect dose administered, Drug dose omission by device, Device delivery system issue, Device use issue, |
||||
ALBUTEROL SULFATE, |
||||
| 64 | 25471329 |
US |
2 | |
Circumstance or information capable of leading to medication error, Device delivery system issue, |
||||
ALBUTEROL SULFATE, |
||||
| 65 | 25471553 |
US |
||
Incorrect dose administered by product, Device delivery system issue, Product use issue, |
||||
ALBUTEROL SULFATE AND BUDESONIDE, |
||||
| 66 | 25471615 |
US |
||
Hypoacusis, Device use issue, Drug ineffective, Device delivery system issue, Device malfunction, Product communication issue, |
||||
| 67 | 25472066 |
US |
2 | |
Circumstance or information capable of leading to medication error, Device delivery system issue, Product dose omission issue, |
||||
ALBUTEROL SULFATE, |
||||
| 68 | 25472115 |
CN |
||
Device delivery system issue, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 69 | 25472197 |
US |
1 | |
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, |
||||
| 70 | 25472804 |
US |
||
Hepatic vascular thrombosis, Varices oesophageal, Asthenia, Weight increased, Device delivery system issue, Wrong technique in product usage process, Product dose omission issue, |
||||
EXENATIDE, |
||||
| 71 | 25472814 |
US |
||
Asthma, Device delivery system issue, Wrong technique in product usage process, Product cleaning inadequate, Device issue, Product dose omission issue, Device breakage, |
||||
ALBUTEROL SULFATE AND BUDESONIDE, |
||||
| 72 | 25472959 |
US |
1 | |
Asthma, Device use issue, Device delivery system issue, |
||||
FLUTICASONE PROPIONATE AND SALMETEROL, |
||||
| 73 | 25473085 |
US |
66 | 2 |
Headache, Dyspnoea, Device delivery system issue, |
||||
FLUTICASONE PROPIONATE AND SALMETEROL, |
||||
| 74 | 25473346 |
CO |
2 | |
Device delivery system issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 75 | 25473403 |
US |
15 | 1 |
Drug dose omission by device, Wrong technique in device usage process, Drug administered in wrong device, Incorrect dose administered by device, Device delivery system issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 76 | 25473821 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 77 | 25473822 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 78 | 25473824 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 79 | 25473865 |
US |
||
Bronchitis, Memory impairment, Fatigue, Visual impairment, Device delivery system issue, Device use issue, Product dose omission issue, Incorrect dose administered, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 80 | 25474007 |
US |
2 | |
Device delivery system issue, Device safety feature issue, |
||||
ABATACEPT, |
||||
| 81 | 25475251 |
US |
65 | 1 |
Drug dose omission by device, Device delivery system issue, |
||||
SOMATROPIN, |
||||
| 82 | 25475556 |
US |
||
Incorrect dose administered, Overdose, Product dose omission issue, Device delivery system issue, |
||||
ALBUTEROL SULFATE AND BUDESONIDE, |
||||
| 83 | 25475576 |
US |
||
Device delivery system issue, Headache, Throat irritation, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 84 | 25475721 |
US |
65 | |
Dyspnoea, Drug ineffective, Incorrect dose administered, Product dose omission issue, Intentional device use issue, Device delivery system issue, Wrong technique in product usage process, Product use issue, |
||||
ALBUTEROL SULFATE AND BUDESONIDE, |
||||
| 85 | 25465708 |
US |
2 | |
Product dose omission issue, Extra dose administered, Product use issue, Device delivery system issue, |
||||
BRIMONIDINE TARTRATE, |
||||
| 86 | 25465966 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 87 | 25466531 |
US |
66 | 2 |
Injection site pain, Injection site swelling, Accidental exposure to product, Device delivery system issue, Drug dose omission by device, |
||||
PREDNISONE, ROSUVASTATIN, LEVOTHYROXINE, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, ALENDRONATE SODIUM, |
||||
| 88 | 25466625 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 89 | 25466661 |
US |
80 | |
Product dose omission issue, Wrong technique in device usage process, Wrong technique in product usage process, Device use issue, Device delivery system issue, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 90 | 25467738 |
US |
63 | 1 |
Off label use, Device delivery system issue, Product container issue, |
||||
PRAMOXINE HYDROCHLORIDE HYDROCORTISONE ACETATE, |
||||
| 91 | 25467977 |
US |
2 | |
Drug ineffective, Device delivery system issue, |
||||
ALBUTEROL SULFATE, |
||||
| 92 | 25467999 |
US |
14 | 1 |
Incorrect dose administered by device, Device physical property issue, Device delivery system issue, |
||||
SOMATROPIN, |
||||
| 93 | 25468137 |
US |
||
Drug dose omission by device, Accidental exposure to product, Device leakage, Exposure via skin contact, Device delivery system issue, |
||||
| 94 | 25469188 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 95 | 25469189 |
US |
||
Drug dose omission by device, Device delivery system issue, Device issue, Wrong technique in product usage process, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 96 | 25469736 |
ES |
||
Device delivery system issue, |
||||
SOMATROPIN, |
||||
| 97 | 25473251 |
40 | 2 | |
Rash, Rash, Pyrexia, Drug ineffective, Device leakage, Device delivery system issue, Arthralgia, Neck pain, |
||||
GUSELKUMAB, |
||||
| 98 | 25464770 |
US |
||
Incorrect dose administered, Product dose omission issue, Overdose, Device delivery system issue, Epilepsy, |
||||
ALBUTEROL SULFATE AND BUDESONIDE, |
||||
| 99 | 25465034 |
US |
72 | 2 |
Bone pain, Nasopharyngitis, Pain in extremity, Device deployment issue, Device delivery system issue, |
||||
ABATACEPT, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, ATENOLOL, |
||||
| 100 | 25463869 |
CN |
||
Device delivery system issue, |
||||
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
2025-07-29