BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFTHEAT

    MDR report key: 4756325 · Received May 4, 2015

    Report

    Report Number
    1314800-2015-00034
    Event Type
    Other
    Date Received
    May 4, 2015
    Date of Event
    January 9, 2013
    Report Date
    May 1, 2015
    Manufacturer
    KAZ, USA, INC.
    Product Code
    IRT
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINT ALLEGED THAT A CONSUMER RECEIVED BURNS ON HIS FACE AND UPPER ARM WHILE USING A HEATING PAD. MEDICAL ATTENTION WAS REQUIRED FOR HIS INJURIES. BURNS OF THIS NATURE ARE MOST LIKELY CAUSED BY THE CONSUMER LAYING OR LEANING AGAINST THE PAD WHICH IS CONTRARY TO PROPER USE INSTRUCTION. NOTE: ALTHOUGH THE CONSUMER ALLEGES THAT THE BURN OCCURRED ON (B)(6) 2013, WE HAVE RECEIVED INFORMATION THAT SUGGESTS THAT THE INCIDENT MAY HAVE OCCURRED ON A DIFFERENT DATE. THIS CALLS INTO QUESTION THE VERACITY OF THE CLAIM AND WHETHER THE INJURY MAY HAVE OCCURRED AS A RESULT OF USE OF A KAZ PRODUCT AT ALL. WE ARE STILL VERY EARLY IN THE PROCESS OF INVESTIGATION. KAZ, USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR LAB ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292290 SOFTHEAT HEATING PAD IRT KAZ, USA, INC. UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK