BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACE HEAT THERAPY PATCH

    MDR report key: 1047397 · Received May 9, 2008

    Report

    Report Number
    2243072-2008-00027
    Event Type
    Other
    Date Received
    May 9, 2008
    Date of Event
    January 8, 2008
    Report Date
    May 7, 2008
    Manufacturer
    BECTON DICKINSON
    Product Code
    IMD
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: EVAL DATE/TIME: 04/09/2008 11:49:110. RC RECEIVED (1) USED ACE HEAT THERAPY PATCH WHICH CONSUMER REPORTS RECEIVING A BURN THAT RESULTED IN SOME SKIN REMOVAL. PRODUCT HAS BEEN FORWARDED TO THE QA DEPT FOR FURTHER REVIEW. CAPA HAS BEEN OPENED AND REASSIGNED FOR FURTHER INVESTIGATION. REGULATORY COMPLIANCE WILL CONTINUE TO MONITOR.

    Description of Event or Problem · 1

    CONSUMER CALLED AND STATED SHE WORE THE HEAT PATCH FOR 7-8 HOURS ON THE LOWER BACK. WHEN SHE REMOVED IT IN THE MORNING, SOME OF HER SKIN CAME OFF WITH IT. INITIAL AND SUBSEQUENT CONTACT FROM THE CONSUMER INDICATES THAT NO MEDICAL ATTENTION WAS NEEDED, HOWEVER, PHOTOS RETURNED (04/22/2008) INDICATE A POSSIBLE 2ND DEGREE BURN.

    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 Other