SUNBEAM 720-905

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-01-09 for SUNBEAM 720-905 manufactured by Sunbeam Products, Inc..

Event Text Entries

[174785941] Consumer admits to laying on the heating pad which is abuse of the product and a violation of the instructions and warnings provided. There is an instruction that states, "do not sit on, against, or crush pad-avoid sharp folds. Place pad on top of and not under the part of body needing heat" and consumer failed to perform that instruction. There is an instruction that states, "do not place anything over the heating pad while in use or plugged in, such as a towel, blanket, clothing, or any other insulating material, and never allow heating pad to wrap around itself" and consumer failed to perform that instruction. There is an instruction that states, "burns can occur regardless of control setting, check skin under pad frequently" and consumer failed to perform that instruction.
Patient Sequence No: 1, Text Type: N, H10


[174785942] Consumer's daughter alleges her mother had leaned against the heating pad while in her recliner watching television and received a burn on her right hip near her buttock. There was not a report of property damage with this incident.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3010805625-2020-00001
MDR Report Key9569295
Report SourceOTHER
Date Received2020-01-09
Date of Report2020-01-24
Date of Event2019-12-14
Date Mfgr Received2020-01-10
Device Manufacturer Date2016-06-29
Date Added to Maude2020-01-09
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 64850
Manufacturer CountryUS
Manufacturer Postal64850
Manufacturer Phone4174557441
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 Received2020-01-09
Returned To Mfg2020-01-10
Model Number720-905
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 33431 US 33431


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-01-09

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