BEUDAMED
    FDA Adverse Event Other Summary report: N

    THERMAL AID

    MDR report key: 5566819 · Received April 8, 2016

    Report

    Report Number
    MW5061576
    Event Type
    Other
    Date Received
    April 8, 2016
    Date of Event
    February 27, 2016
    Report Date
    February 29, 2016
    Manufacturer
    PACIFIC SHORE HOLDINGS, INC.
    Product Code
    IME
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2016 THE SUBMITTER'S GRANDFATHER WAS SICK WITH THE FLU. THE SUBMITTER'S DAUGHTER PUT THE BEAR IN THE MICROWAVE FOR 45 SECONDS AND THEN WENT TO GO PUT THE BEAR ON HER CHILD'S STOMACH. HOWEVER, THE SUBMITTER'S GRANDDAUGHTER WAS SLEEPING. THE SUBMITTER'S DAUGHTER DECIDED TO PUT THE BEAR ON HER NECK. THE SUBMITTER'S DAUGHTER NOTICED A BURN ODOR. THE SUBMITTER'S DAUGHTER WRAPPED THE BEAR IN A TOWEL AND PLACED IT IN THE LAUNDRY BASKET. APPROXIMATELY 10 MINUTES LATER THE SUBMITTER'S DAUGHTER AND SON-IN-LAW NOTICED A STRONG BURN ODOR. WHEN THEY CHECKED THE LAUNDRY ROOM THEY NOTICED THE BEAR AND NEARBY CLOTHES WERE IN FLAMES. THE LAUNDRY BASKET WAS TAKEN OUT OF THE HOME. THE SUBMITTER STATES THE TOP HALF OF THE BEAR IS COMPLETELY BURNED. THE SUBMITTER DOES NOT PLAN TO CONTACT THE FIRM DIRECTLY. THE SUBMITTER STATES THAT HER GRANDDAUGHTER HAS PLAYED WITH THE BEAR AS A TOY BUT THE SUBMITTER IS NOT SURE IF THE BEAR HAS EVER BEEN PUT IN THE MICROWAVE BEFORE (B)(6) 2016. THE SUBMITTER BELIEVES THE BEAR IS DEFECTIVE. INCIDENT LOCATION: HOME/APARTMENT/CONDOMINIUM - (B)(6), UNITED STATES. RETAILER: (B)(6). RETAILER STATE: (B)(6). PURCHASE DATE: (B)(6) 2015. THE PRODUCT WAS NOT DAMAGED BEFORE THE INCIDENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216922 THERMAL AID THERMAL AID 100 PERCENT NATURAL HEATING AND COOLING PACK PINK BEAR IME PACIFIC SHORE HOLDINGS, INC. PINK BEAR

    Patients

    Seq Age Sex Outcome Treatment
    1