Drug:
Reaction: DEVICE MALFUNCTION
20260101 - 20261231
No. 501 - 600
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 501 | 26881013 |
US |
55 | |
Device malfunction, Accidental exposure to product, Exposure via skin contact, Drug dose omission by device, |
||||
INFLIXIMAB-DYYB, |
||||
| 502 | 26881038 |
US |
60 | |
Device malfunction, Accidental exposure to product, Exposure via skin contact, Product dose omission issue, |
||||
INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB, |
||||
| 503 | 26881054 |
US |
||
Device malfunction, Needle issue, Accidental exposure to product, Exposure via skin contact, |
||||
INFLIXIMAB-DYYB, |
||||
| 504 | 26881090 |
US |
19 | |
Needle issue, Device malfunction, Exposure via skin contact, Accidental exposure to product, Incorrect dose administered by device, Product storage error, Therapy interrupted, |
||||
INFLIXIMAB-DYYB, |
||||
| 505 | 26881101 |
US |
31 | |
Device malfunction, Incorrect dose administered by device, Accidental exposure to product, Exposure via skin contact, |
||||
INFLIXIMAB-DYYB, |
||||
| 506 | 26881119 |
CN |
2 | |
Device malfunction, Incorrect dose administered, Drug ineffective, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 507 | 26881162 |
US |
51 | |
Product prescribing error, Device malfunction, Prescribed underdose, |
||||
NEMOLIZUMAB-ILTO, ADALIMUMAB-ADAZ, |
||||
| 508 | 26875809 |
US |
2 | |
Chronic obstructive pulmonary disease, Drug ineffective, Product use issue, Device malfunction, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 509 | 26873040 |
US |
66 | |
Product dose omission issue, Device malfunction, Device leakage, |
||||
| 510 | 26873045 |
US |
38 | 2 |
Drug dose omission by device, Device malfunction, Product leakage, |
||||
| 511 | 26873049 |
US |
47 | 2 |
Product dose omission issue, Device malfunction, |
||||
ORAL SEMAGLUTIDE, ORAL SEMAGLUTIDE, ORAL SEMAGLUTIDE, ORAL SEMAGLUTIDE, |
||||
| 512 | 26873549 |
US |
2 | |
Administration site indentation, Appetite disorder, Drug dose omission by device, Device malfunction, Drug ineffective, |
||||
| 513 | 26873558 |
US |
||
Malaise, Vomiting, Abdominal pain upper, Incorrect dose administered, Device malfunction, |
||||
| 514 | 26873587 |
US |
0 | 2 |
Injection site discharge, Product dose omission issue, Weight increased, Hunger, Device malfunction, |
||||
| 515 | 26874097 |
US |
2 | |
Oedema peripheral, Device malfunction, |
||||
TREPROSTINIL, TREPROSTINIL, AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATED, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, PREDNISONE, RITUXIMAB, ALBUTEROL SULFATE, SILDENAFIL CITRATE, SILDENAFIL, NINTEDANIB, OXYGEN, 0XYGEN, OXYMETAZOLINE HYDROCHLORIDE, OXYMETAZOLINE HYDROCHLORIDE., VALSARTAN, VALSARTAN ORAL, BENZONATATE, CARVEDILOL, IPRATROPIUM BROMIDE, LORATADINE, LORATADINE ORAL, |
||||
| 516 | 26875030 |
US |
2 | |
Device malfunction, Incorrect dose administered by device, Device leakage, |
||||
SECUKINUMAB, |
||||
| 517 | 26875038 |
US |
32 | 2 |
Food craving, Device malfunction, Product dose omission issue, Needle issue, |
||||
| 518 | 26868092 |
US |
67 | 1 |
Incorrect dose administered by device, Device malfunction, Device leakage, |
||||
BENRALIZUMAB, BENRALIZUMAB, |
||||
| 519 | 26868950 |
US |
44 | 2 |
Thinking abnormal, Polymenorrhoea, Heavy menstrual bleeding, Insomnia, Headache, Nausea, Somnolence, Product dose omission issue, Device malfunction, |
||||
AMANTADINE, |
||||
| 520 | 26869000 |
US |
||
Incorrect dose administered, Device malfunction, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 521 | 26869191 |
US |
76 | |
Device malfunction, Product dose omission issue, |
||||
GUSELKUMAB, GUSELKUMAB, GUSELKUMAB, GUSELKUMAB, |
||||
| 522 | 26869215 |
US |
14 | |
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 523 | 26869459 |
US |
||
Device malfunction, Drug dose omission by device, |
||||
GUSELKUMAB, |
||||
| 524 | 26869640 |
US |
84 | |
Headache, Diarrhoea, Abdominal pain, Pollakiuria, Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 525 | 26869943 |
US |
44 | 1 |
Nervousness, Device malfunction, Incorrect dose administered by device, |
||||
| 526 | 26870064 |
US |
42 | 2 |
Injection site mass, Injection site discharge, Incorrect dose administered, Device malfunction, Device leakage, |
||||
| 527 | 26870111 |
US |
2 | |
Pain, Device malfunction, Accidental exposure to product, Product complaint, |
||||
OMALIZUMAB, |
||||
| 528 | 26870180 |
US |
1 | |
Application site discolouration, Application site swelling, Application site induration, Product dose omission issue, Device malfunction, Device malfunction, Application site discolouration, Application site swelling, Application site induration, Product dose omission issue, |
||||
PEGFILGRASTIM-CBQV, PEGFILGRASTIM-CBQV, |
||||
| 529 | 26870260 |
US |
2 | |
Device malfunction, No adverse event, Device issue, |
||||
LIRAGLUTIDE, |
||||
| 530 | 26870495 |
US |
33 | 2 |
Accidental exposure to product, Device malfunction, Off label use, No adverse event, |
||||
OMALIZUMAB, |
||||
| 531 | 26870575 |
US |
2 | |
Device operational issue, Device malfunction, Drug dose omission by device, Paraesthesia oral, |
||||
SECUKINUMAB, |
||||
| 532 | 26870751 |
US |
77 | |
Device malfunction, Product after taste, |
||||
TREPROSTINIL, TREPROSTINIL, ACYCLOVIR, INSULIN LISPRO, AMLODIPINE BESYLATE, ERGOCALCIFEROL, NITROGLYCERIN, METOPROLOL SUCCINATE, METOPROLOL SUCCINATE ER TABLETS, SPIRONOLACTONE, DULAGLUTIDE, ESCITALOPRAM OXALATE, ESCITALOPRAM, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, |
||||
| 533 | 26871163 |
US |
1 | |
Cough, Product use issue, Product dose omission issue, Device malfunction, |
||||
ALBUTEROL SULFATE AND BUDESONIDE, |
||||
| 534 | 26871784 |
US |
8 | 1 |
Device malfunction, |
||||
SOMATROPIN, |
||||
| 535 | 26871908 |
US |
65 | 2 |
Product quality issue, Device malfunction, Asthma, Oxygen saturation decreased, Product dose omission issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, METHYLPREDNISOLONE, |
||||
| 536 | 26872092 |
US |
1 | |
Lung neoplasm malignant, Cough, Device malfunction, Incorrect dose administered by device, Product dose omission issue, Lung disorder, |
||||
| 537 | 26872553 |
US |
1 | |
Memory impairment, Device malfunction, Device delivery system issue, Device use error, Wrong technique in device usage process, Product use issue, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 538 | 26872849 |
US |
69 | 2 |
Product prescribing issue, Device malfunction, |
||||
FLUTICASONE PROPIONATE AND SALMETEROL, FLUTICASONE PROPIONATE AND SALMETEROL, FLUTICASONE PROPIONATE AND SALMETEROL, FLUTICASONE PROPIONATE AND SALMETEROL, |
||||
| 539 | 26862802 |
JP |
||
Device infusion issue, Product dose omission issue, Device malfunction, |
||||
GOLIMUMAB, |
||||
| 540 | 26862821 |
US |
78 | 2 |
Product administration error, Accidental exposure to product, Underdose, Device malfunction, Throat clearing, |
||||
TEZEPELUMAB-EKKO, TEZEPELUMAB-EKKO, |
||||
| 541 | 26862873 |
US |
48 | 1 |
No adverse event, Product dose omission issue, Device leakage, Device defective, Device malfunction, |
||||
VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, |
||||
| 542 | 26863148 |
US |
2 | |
Device malfunction, Accidental exposure to product, Device difficult to use, Drug dose omission by device, |
||||
SECUKINUMAB, SECUKINUMAB, |
||||
| 543 | 26863182 |
US |
2 | |
Dyspnoea, Device malfunction, Incorrect dose administered, Off label use, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 544 | 26863413 |
US |
78 | 2 |
Product dose omission issue, Product leakage, Device malfunction, |
||||
GUSELKUMAB, |
||||
| 545 | 26863446 |
US |
||
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 546 | 26863470 |
US |
78 | 1 |
Renal disorder, Product dose omission issue, Device malfunction, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 547 | 26863762 |
US |
1 | |
Product dose omission issue, Device malfunction, No adverse event, Device defective, |
||||
TOCILIZUMAB, |
||||
| 548 | 26863891 |
EU |
1 | |
Product dose omission issue, Device delivery system issue, Device malfunction, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 549 | 26863993 |
US |
||
Device malfunction, |
||||
NITRIC OXIDE, NITRIC OXIDE, |
||||
| 550 | 26864709 |
US |
84 | |
Drug dose omission by device, Wrong technique in device usage process, Device mechanical issue, Device malfunction, No adverse event, |
||||
TIOTROPIUM BROMIDE, TIOTROPIUM BROMIDE, |
||||
| 551 | 26864737 |
US |
1 | |
Injection site haemorrhage, Exposure via skin contact, Incorrect dose administered, Accidental exposure to product, Device malfunction, |
||||
ADALIMUMAB-ADAZ, ADALIMUMAB-ADAZ, |
||||
| 552 | 26865235 |
US |
41 | 2 |
Incorrect dose administered, Postural orthostatic tachycardia syndrome, Oedema, Tourette^s disorder, Angioedema, Mastocytosis, Accidental exposure to product, Hypoacusis, Deafness, Surgery, Device malfunction, Cardiac arrest, Cerebrovascular accident, Seizure, Autism spectrum disorder, Urticaria, Exposure via skin contact, Device defective, Carbohydrate antigen 125 increased, Myocardial infarction, Syncope, Cervical vertebral fracture, Fall, Haemorrhoids thrombosed, Vaginal scarring, Pelvic floor dysfunction, Rash, Malaise, |
||||
OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, PREDNISONE, PREDNISONE, PREDNISONE, PREDNISONE, METHOCARBAMOL, METHOCARBAMOL TABLETS, HYDROMORPHONE HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE, HYDROXYZINE, FUROSEMIDE, FAMOTIDINE, PANTOPRAZOLE, MONTELUKAST, ALBUTEROL SULFATE, ALBUTEROL, EPINEPHRINE, LORATADINE, LORATADINE ORAL, DIPHENHYDRAMINE HYDROCHLORIDE, FLUCONAZOLE, NYSTATIN, NYSTATIN OINTMENT, NYSTATIN CREAM, |
||||
| 553 | 26865660 |
US |
||
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 554 | 26865894 |
EU |
1 | |
Circumstance or information capable of leading to device use error, Device malfunction, |
||||
| 555 | 26866095 |
US |
75 | 2 |
Device malfunction, Incorrect dose administered, Product dose omission issue, Disturbance in attention, Wrong technique in product usage process, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 556 | 26866671 |
US |
29 | |
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 557 | 26866697 |
US |
1 | |
Device use issue, Drug ineffective, Product use issue, Product knowledge deficit, Drug delivery system issue, Device malfunction, |
||||
ALBUTEROL SULFATE AND BUDESONIDE, |
||||
| 558 | 26866740 |
US |
64 | 2 |
Device malfunction, Product dose omission issue, Device leakage, No adverse event, |
||||
VEDOLIZUMAB, VEDOLIZUMAB, |
||||
| 559 | 26866845 |
US |
42 | 2 |
Device issue, No adverse event, Underdose, Device defective, Device malfunction, |
||||
OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, |
||||
| 560 | 26867053 |
US |
41 | 2 |
Colitis ulcerative, Device malfunction, Incorrect dose administered, Product dose omission issue, Device leakage, Device defective, |
||||
VEDOLIZUMAB, VEDOLIZUMAB, SERTRALINE HYDROCHLORIDE, ERGOCALCIFEROL, |
||||
| 561 | 26867576 |
US |
48 | |
Product dose omission issue, Device malfunction, |
||||
| 562 | 26867581 |
US |
2 | |
Product use in unapproved indication, Product dose omission issue, Device malfunction, |
||||
ORAL SEMAGLUTIDE, ORAL SEMAGLUTIDE, |
||||
| 563 | 26867583 |
US |
||
Wrong technique in product usage process, Device malfunction, Incorrect dose administered, |
||||
ORAL SEMAGLUTIDE, |
||||
| 564 | 26867585 |
US |
||
Device use error, Device malfunction, |
||||
ORAL SEMAGLUTIDE, |
||||
| 565 | 26867586 |
US |
46 | |
Product dose omission issue, Device malfunction, |
||||
ORAL SEMAGLUTIDE, |
||||
| 566 | 26867606 |
US |
||
Device malfunction, Incorrect dose administered, |
||||
GUSELKUMAB, |
||||
| 567 | 26867904 |
CA |
||
Tracheal haemorrhage, Psychomotor hyperactivity, Device malfunction, |
||||
PROPOFOL, |
||||
| 568 | 26867927 |
US |
2 | |
Device malfunction, Product dose omission issue, Device delivery system issue, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 569 | 26857871 |
US |
25 | |
Incorrect dose administered, Product leakage, Device malfunction, |
||||
GUSELKUMAB, |
||||
| 570 | 26857902 |
US |
73 | 2 |
Mental disorder, Product dose omission issue, Device malfunction, Device delivery system issue, Device defective, |
||||
TEZEPELUMAB-EKKO, TEZEPELUMAB-EKKO, |
||||
| 571 | 26858037 |
US |
2 | |
Device malfunction, Incorrect disposal of product, Product dose omission issue, Product leakage, Device malfunction, |
||||
GUSELKUMAB, |
||||
| 572 | 26858155 |
US |
38 | |
Skin burning sensation, Device malfunction, Incorrect dose administered, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 573 | 26858435 |
CA |
2 | |
Osteonecrosis, Staphylococcal infection, Device malfunction, Device leakage, Product administration interrupted, Product administration error, |
||||
| 574 | 26858457 |
US |
2 | |
Device malfunction, Injection site pain, Drug dose omission by device, |
||||
SECUKINUMAB, SECUKINUMAB, |
||||
| 575 | 26858459 |
US |
73 | 1 |
Incorrect dose administered by device, Device issue, Device malfunction, No adverse event, |
||||
LIRAGLUTIDE, LIRAGLUTIDE, LISINOPRIL, DAPAGLIFLOZIN, FINASTERIDE, DOXAZOSIN, DOXAZOSIN MESYLATE, |
||||
| 576 | 26858674 |
US |
61 | |
Device malfunction, Product dose omission issue, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 577 | 26858941 |
US |
2 | |
Device malfunction, Device malfunction, No adverse event, |
||||
PEGFILGRASTIM-CBQV, |
||||
| 578 | 26858954 |
US |
17 | 1 |
Device malfunction, Product quality issue, Product dose omission issue, Device use error, Nasal congestion, Sneezing, Nasal disorder, |
||||
OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, ALBUTEROL SULFATE, ALBUTEROL, BUDESONIDE, |
||||
| 579 | 26859050 |
US |
1 | |
Product dose omission issue, Incorrect dose administered by device, Device malfunction, Product quality issue, Device issue, Illness, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 580 | 26859177 |
US |
36 | 2 |
Device malfunction, Inappropriate schedule of product administration, Pregnancy, No adverse event, |
||||
VEDOLIZUMAB, VEDOLIZUMAB, |
||||
| 581 | 26860015 |
CA |
||
Device malfunction, |
||||
ENOXAPARIN SODIUM, |
||||
| 582 | 26860483 |
US |
40 | |
Product dose omission issue, Device malfunction, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 583 | 26860666 |
US |
24 | |
Needle issue, Device malfunction, Drug dose omission by device, |
||||
ADALIMUMAB-AATY, ADALIMUMAB-AATY, |
||||
| 584 | 26860718 |
US |
84 | |
Burning sensation, Device malfunction, Device malfunction, Accidental exposure to product, Exposure via skin contact, |
||||
ADALIMUMAB-AATY, ADALIMUMAB-AATY, |
||||
| 585 | 26860730 |
US |
61 | |
Device malfunction, Exposure via skin contact, Accidental exposure to product, |
||||
ADALIMUMAB-AATY, ADALIMUMAB-AATY, |
||||
| 586 | 26860768 |
US |
63 | 2 |
Nephrolithiasis, Hepatic enzyme increased, Blood glucose increased, Blood insulin increased, Device malfunction, Product leakage, Product dose omission issue, |
||||
GUSELKUMAB, GUSELKUMAB, |
||||
| 587 | 26861181 |
US |
8 | 2 |
Device malfunction, |
||||
NITRIC OXIDE, NITRIC OXIDE, |
||||
| 588 | 26861327 |
US |
2 | |
Device malfunction, |
||||
MEDROXYPROGESTERONE ACETATE, |
||||
| 589 | 26861920 |
US |
68 | |
Product dose omission issue, Device malfunction, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 590 | 26862109 |
US |
75 | 2 |
Expired product administered, Device mechanical issue, Device malfunction, |
||||
FLUTICASONE PROPIONATE AND SALMETEROL, |
||||
| 591 | 26862304 |
US |
2 | |
Drug dose omission by device, Device issue, Device malfunction, |
||||
| 592 | 26865404 |
2 | ||
Device malfunction, Air in device issue, |
||||
| 593 | 26865719 |
69 | 2 | |
Device malfunction, Incorrect dose administered by device, |
||||
ETANERCEPT, ETANERCEPT, ETANERCEPT, |
||||
| 594 | 26852556 |
US |
53 | 2 |
Cough, Device malfunction, |
||||
| 595 | 26852664 |
US |
71 | |
Device malfunction, Herpes zoster, Accidental exposure to product, Exposure via skin contact, Drug dose omission by device, |
||||
ADALIMUMAB-AATY, ADALIMUMAB-AATY, FLUOXETINE HYDROCHLORIDE, TENOFOVIR ALAFENAMIDE, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, ARIPIPRAZOLE, LORATADINE, LORATADINE TABLET, |
||||
| 596 | 26852665 |
US |
83 | |
Device malfunction, Drug dose omission by device, |
||||
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, |
||||
| 597 | 26852741 |
US |
63 | |
Drug dose omission by device, Device malfunction, |
||||
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, |
||||
| 598 | 26852807 |
US |
77 | |
Accidental exposure to product, Exposure via skin contact, Product dose omission issue, Device malfunction, |
||||
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, |
||||
| 599 | 26852819 |
US |
55 | |
Injection site bruising, Needle issue, Device malfunction, Product use issue, Drug dose omission by device, |
||||
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, |
||||
| 600 | 26852831 |
US |
55 | |
Device malfunction, Exposure via skin contact, Accidental exposure to product, Suspected off label use, |
||||
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, |
||||
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