BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACE HEAT THERAPY PATCH

    MDR report key: 1047396 · Received May 9, 2008

    Report

    Report Number
    2243072-2008-00026
    Event Type
    Other
    Date Received
    May 9, 2008
    Date of Event
    March 21, 2008
    Report Date
    May 7, 2008
    Manufacturer
    BECTON DICKINSON
    Product Code
    OMW
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: EVAL DATE/TIME: 2008, 11:49:110. RC RECEIVED (2) SEALED ACE HEAT THERAPY PATCHES (LOW RU 23Y), EX 2010 04) FROM LOT REPORTED AND ONE EMPTY WRAPPER FOR ACE LARGE HEAT THERAPY PATCH WHICH CONSUMER REPORTS RECEIVING A NASTY BURN. PRODUCT HAS BEEN FORWARDED TO THE QUALITY ASSURANCE 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 THAT HER DAUGHTER RECEIVED A BURN FROM USING THE ACE HEAT THERAPY PATCH ON HER BACK. INITIAL AND SUBSEQUENT CONTACT FROM THE CONSUMER INDICATES THAT NO MEDICAL ATTENTION WAS NEEDED, HOWEVER, PHOTOS RETURNED (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 OMW BECTON DICKINSON NA RU23Y

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other