BEUDAMED
    FDA Adverse Event Other Summary report: N

    ELEPHANT THERMAL AID PALS

    MDR report key: 5581025 · Received February 2, 2016

    Report

    Report Number
    MW5061718
    Event Type
    Other
    Date Received
    February 2, 2016
    Date of Event
    November 19, 2015
    Manufacturer
    PACIFIC SHORE HOLDINGS INC.
    Product Code
    IME
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2015 THE CONSUMER INDICATES THAT SHE PLACED THE TOY INSIDE THE MICROWAVE FOR UNDER A MINUTE AND WHEN SHE TOOK THE PRODUCT OUT, IT WAS SCORCHED AND MELTED ON THE BACK. THE CONSUMER STATES THAT THE TOY HAD A DISTINCT SMELL SIMILAR TO BURNT PLASTIC BUT NOT QUITE. THE CONSUMER THREW THE PRODUCT AWAY IN HER KITCHEN WASTE BASKET. BECAUSE THE SMELL WAS STILL LINGERING AFTER A FEW HOURS, SHE WENT TO PICK IT UP FROM THE TRASH CAN TO PLACE IT OUTSIDE INSTEAD. WHEN SHE SAW THE THERMAL PAD, THE ELEPHANT HEAD HAD COMPLETELY MELTED AND IT HAD STARTED TO SMOTHER TOWARDS THE BODY OF THE TOY. THE CONSUMER TOOK THE WASTE BASKET OUTSIDE AND HOSED IT INSIDE WITH WATER, THE TOY STILL INSIDE AND ALREADY DRENCHED. THE CONSUMER REMOVED THE ELEPHANT TOY FROM THE WASTE BASKET AND IS NOW IN HER POSSESSION. THE CONSUMER'S DAUGHTER CONTACTED THE MANUFACTURER AND EXPLAINED THE SITUATION. THE REPRESENTATIVE SHE SPOKE TO INFORMED THE CONSUMER'S DAUGHTER THAT THEY WOULD LOOK INTO THE MATTER AND CALL THEM BACK BUT THEY NEVER DID. THE CONSUMER HAS NO INJURIES NOR PREVIOUS INCIDENTS TO REPORT. THE CONSUMER BELIEVES THIS PRODUCT POSES A SAFETY HAZARD TO CONSUMERS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64429 ELEPHANT THERMAL AID PALS ELEPHANT THERMAL AID PALS IME PACIFIC SHORE HOLDINGS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1