BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTHEAT

    MDR report key: 3131405 · Received May 14, 2013

    Report

    Report Number
    1314800-2013-00021
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 12, 2013
    Manufacturer
    KAZ, INC.
    Product Code
    IRT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED RECEIVING BURNS TO HER LOWER LEG FROM THE HEATING PAD. SHE REPORTED LAYING ON TOP OF THE HEATING PAD WHILE IN BED. THE INSTRUCTIONS FOR PROPER USE STATE NOT TO LAY OR LEAN AGAINST THE HEATING PAD OR TO USE WHILE IN BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213927 SOFTHEAT HEATING PAD IRT KAZ, INC. HP950 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other