BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUNBEAM

    MDR report key: 6110127 · Received November 17, 2016

    Report

    Report Number
    3007790958-2016-00179
    Event Type
    Injury
    Date Received
    November 17, 2016
    Date of Event
    October 19, 2016
    Report Date
    September 21, 2017
    Manufacturer
    SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTI
    Product Code
    IRT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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, "BURNS CAN OCCUR REGARDLESS OF CONTROL SETTING, CHECK SKIN UNDER PAD FREQUENTLY" AND CONSUMER FAILED TO PERFORM THAT INSTRUCTION.

    Additional Manufacturer Narrative · 1

    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, "BURNS CAN OCCUR REGARDLESS OF CONTROL SETTING, CHECK SKIN UNDER PAD FREQUENTLY" AND CONSUMER FAILED TO PERFORM THAT INSTRUCTION. HEATING PAD IS BUNCHED/CRUSHED WHICH SHOWS ABUSE OF THE PRODUCT AND A VIOLATION OF THE INSTRUCTIONS AND WARNINGS PROVIDED.

    Description of Event or Problem · 1

    CONSUMER STATES SHE WAS LAYING ON A HEATING PAD IN BED AND IS ALLEGING THAT SHE RECEIVED BURNS TO HER BUTTOCKS AND LEG.

    Description of Event or Problem · 1

    CONSUMER STATES SHE WAS LAYING ON A HEATING PAD IN BED AND IS ALLEGING THAT SHE RECEIVED BURNS TO HER BUTTOCKS AND LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759664 SUNBEAM HEATING PAD IRT SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTI 532

    Patients

    Seq Age Sex Outcome Treatment
    1 Other