BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMPI

    MDR report key: 2201938 · Received August 5, 2011

    Report

    Report Number
    MW5021652
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    September 27, 2010
    Report Date
    August 5, 2011
    Manufacturer
    EMPI
    Product Code
    EGJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT SUFFERED A BURN ON HER LEG AFTER EMPI HYBRESIS PATCH WAS APPLIED AND CONTROLLER TURNED ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMPI EMPI HYBRESIS PATCH EGJ EMPI 82840

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other