BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BODI HEAT NECK SHOULDER WRIST

    MDR report key: 2973669 · Received February 14, 2013

    Report

    Report Number
    2431332-2013-00001
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 17, 2013
    Manufacturer
    OKAMOTO U.S.A., INC.
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CONSUMER COMPLAINED THAT SHE SUFFERED FROM A RASH AND BURNS AFTER USING THE BEYOND BODIHEAT NECK SHOULDER WRIST PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66291 BODI HEAT NECK SHOULDER WRIST HOT OR COLD DISPOSABLE PACK IMD OKAMOTO U.S.A., INC. 028373769836 054

    Patients

    Seq Age Sex Outcome Treatment
    1 Other