BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFTHEAT

    MDR report key: 2550404 · Received April 17, 2012

    Report

    Report Number
    1314800-2012-00023
    Event Type
    Other
    Date Received
    April 17, 2012
    Date of Event
    April 9, 2012
    Report Date
    April 12, 2012
    Manufacturer
    KAZ INC
    Product Code
    IRT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED HER HUSBAND WAS LAYING ON THE HEATING PAD WHICH CAUSED SECOND DEGREE BURNS TO HIS BACK. THE PROPER USE INSTRUCTIONS WARN AGAINST LAYING ON THE HEATING PAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTHEAT HEATING PAD IRT KAZ INC HP750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other