BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMA CARE

    MDR report key: 2163535 · Received July 7, 2011

    Report

    Report Number
    MW5021305
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 7, 2011
    Manufacturer
    PFIZER
    Product Code
    IMD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I USED THERMACARE WRAPS AND FOR THE SECOND TIME RECEIVED BLISTERS AND BURNS FROM THE PRODUCT. DATES OF USE: (B)(6) 2011 - (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMA CARE HEAT WRAPS IMD PFIZER UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention