SUNBEAM 829

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-27 for SUNBEAM 829 manufactured by Sunbeam Products, Inc..

Event Text Entries

[184627397] Consumer alleges her heating pad caught on fire. There was not a report of personal injury or property damage with this incident.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3010805625-2020-00016
MDR Report Key9763682
Report SourceCONSUMER
Date Received2020-02-27
Date of Report2020-03-19
Date Mfgr Received2020-03-04
Device Manufacturer Date2014-10-20
Date Added to Maude2020-02-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMICHAEL MILES
Manufacturer Street303 NELSON AVE.
Manufacturer CityNEOSHO, MO
Manufacturer CountryUS
Manufacturer Phone4557441
Manufacturer G1ZHEIJANG LUMENG HEALTH & TECHNOLOGY CO., LTD
Manufacturer StreetNORTHWEST OF QUNXIAN ROAD AND CENTER AVENUE
Manufacturer CityPAOJIANG, 31200
Manufacturer CountryCH
Manufacturer Postal Code31200
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSUNBEAM
Generic NameHEATING PAD
Product CodeIRT
Date Received2020-02-27
Returned To Mfg2020-03-04
Model Number829
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSUNBEAM PRODUCTS, INC.
Manufacturer Address2381 EXECUTIVE CENTER DR. BOCA RATON, FL US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-27

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