BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACE HEAT THERAPY PATCH

    MDR report key: 1030007 · Received April 9, 2008

    Report

    Report Number
    2243072-2008-00017
    Event Type
    Injury
    Date Received
    April 9, 2008
    Date of Event
    March 24, 2008
    Report Date
    April 7, 2008
    Manufacturer
    BECTON DICKINSON
    Product Code
    IMD
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RECEIVED TO DATE, IF PRODUCT IS RETURNED, ANALYSIS WILL BE CONDUCTED. UNABLE TO RUN COMPLAINT HISTORY CHECK OR DEVICE HISTORY REVIEW AS LOT NUMBER IS UNK. REGULATORY COMPLIANCE WILL CONTINUE TO MONITOR ON MONTHLY TREND REPORTS.

    Description of Event or Problem · 1

    CONSUMER'S REP INDICATED THAT CONSUMER RECEIVED A BURN ON THE BACK OF HER LEG AFTER WEARING HEAT PATCH FOR (3 1/2) HOURS. CONSUMER SOUGHT MEDICAL TREATMENT AT ER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACE HEAT THERAPY PATCH HEAT THERAPY PATCH IMD BECTON DICKINSON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R