BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFTHEAT

    MDR report key: 2143141 · Received June 21, 2011

    Report

    Report Number
    1314800-2011-00025
    Event Type
    Other
    Date Received
    June 21, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 7, 2011
    Manufacturer
    KAZ INC
    Product Code
    IRT
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED RECEIVING A BURN TO HER RIGHT BREAST FROM THE HEATING PAD. SHE STATED FEELING A "PINCH" AND IT HAS RESULTED IN A SCAR. THE INCIDENT WAS NOT REPORTED FOR THREE MONTHS AND SHE DID NOT SEEK MEDICAL ATTENTION AT ANY POINT. EVENTS OF THIS NATURE ARE CAUSED BY PLACING THE HEATING PAD BETWEEN THE BODY AND AN EXTERNAL SURFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTHEAT HEATING PAD IRT KAZ INC HP215 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other