BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALGREENS HOT AND COLD BACK THERAPY WRAP

    MDR report key: 5770152 · Received July 5, 2016

    Report

    Report Number
    1460851-2016-00003
    Event Type
    Injury
    Date Received
    July 5, 2016
    Report Date
    July 5, 2016
    Manufacturer
    SHANGHAI INTCO MEDICAL SUPPLY CO. LTD.
    Product Code
    IME
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    USER CLAIMED THAT THE HOT/COLD PAD BROKE AND CAUSED THE INTERIOR CONTENTS TO LEAK ON USER DURING USE. USER CLAIMED THAT THIS CAUSED SECOND AND THIRD DEGREE BURNS, WHICH WERE TREATED THROUGH OPERATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423944 WALGREENS HOT AND COLD BACK THERAPY WRAP HOT AND COLD BACK THERAPY WRAP IME SHANGHAI INTCO MEDICAL SUPPLY CO. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization