BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTION PATCH

    MDR report key: 1002845 · Received February 21, 2008

    Report

    Report Number
    MW5005650
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    February 8, 2008
    Report Date
    February 21, 2008
    Manufacturer
    EMPI
    Product Code
    EGJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT STATED, THAT SHE EXPERIENCED A STINGING SENSATION UNDER THE DISPERSIVE ELECTRODE OF THE ACTION PATCH THAT WAS PLACED ON HER IN 2008. SHE KEPT THE PATCH ON FOR APPROX 1 1/2 HOURS UNTIL LIGHT TURNED OFF, AS SHE WAS INSTRUCTED TO DO. SHE THEN REMOVED THE PATCH AND NOTED SEVERAL SMALL BLISTERS. SHE PRESENTED TO THE HAND THERAPY CLINIC THREE DAYS LATER WITH LOCALIZED REDNESS AND 3-4 AREAS OF 2ND DEGREE BURNS, THE LARGEST <4MM IN DIAMETER. ALL WOUNDS WERE HEALING WELL. EMPI COMPANY HAS BEEN NOTIFIED OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTION PATCH IONTOPHORESIS PATCH EGJ EMPI 68840

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other