BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNBEAM

    MDR report key: 11657855 · Received April 13, 2021

    Report

    Report Number
    3010805625-2021-00042
    Event Type
    Malfunction
    Date Received
    April 13, 2021
    Report Date
    April 13, 2021
    Manufacturer
    SUNBEAM PRODUCTS, INC.
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. HEATING PAD IS BUNCHED/CRUSHED WHICH SHOWS ABUSE OF THE PRODUCT AND A VIOLATION OF THE INSTRUCTIONS AND WARNINGS PROVIDED. THIS INCIDENT IS THE DIRECT RESULT OF CONSUMER MISUSE/ABUSE OF THE PRODUCT.

    Description of Event or Problem · 1

    CONSUMER ALLEGES THE HEATING PAD WAS TOO HOT AND DISCOLORED THE COVER. THERE WAS NOT A REPORT OF PERSONAL INJURY OR PROPERTY DAMAGE WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558145 SUNBEAM HEATING PAD IRT SUNBEAM PRODUCTS, INC. 731

    Patients

    Seq Age Sex Outcome Treatment
    1