BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACE HEAT THERAPY PATCH

    MDR report key: 1020745 · Received March 27, 2008

    Report

    Report Number
    2243072-2008-00014
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    March 17, 2008
    Report Date
    March 26, 2008
    Manufacturer
    BECTON DICKINSON
    Product Code
    IMD
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    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 UNKNOWN. REGULATORY COMPLIANCE WILL CONTINUE TO MONITOR ON MONTHLY TREND REPORTS.

    Description of Event or Problem · 1

    CUSTOMER INDICATED THAT HEAT PATCH WAS WORN FOR EIGHT (8) HOURS ON LOWER LEFT BACK WHICH CAUSED 2ND DEGREE BURN AND BLISTERS. CONSUMER DID SEEK MEDICAL ATTENTION THROUGH COMPANY NURSE AND RECEIVED BURN OINTMENTS AS TREATMENT.

    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 Required Intervention