BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYBRESIS

    MDR report key: 2073089 · Received April 29, 2011

    Report

    Report Number
    1721293-2011-00002
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    March 23, 2011
    Report Date
    April 28, 2011
    Manufacturer
    EMPI, INC.
    Product Code
    EGJ
    PMA / PMN Number
    K072946
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION. THREE UNUSED PATCHES OF THE SAME LOT NUMBER WERE RETURNED. ALL MET PHYSICAL AND ELECTRICAL SPECIFICATIONS. THE USER MANUAL FOR THE HYBRESIS PATCH STATES: ADVISE THE PATIENT TO REMOVE ELECTRODES IF ANY UNDUE SENSATION OF PAIN OR BURNING OCCURS DURING THE TREATMENT AND TO REPORT DISCOMFORT TO CLINIC. APPLY THE HYDRATED PATCH SO THAT THE DRUG PAD IS OVER THE TREATMENT SITE AND SECURE IT BY PRESSING THE ADHESIVE BORDER. AVOID PRESSING DIRECTLY OVER THE PADS. PRESSING DIRECTLY ON THE PADS CAN CAUSE LEAKAGE THAT WILL COMPROMISE ADHESION TO THE PATIENT. NOTE: DO NOT TAPE OR BIND THE PATCH DURING TREATMENT. DO NOT APPLY HOT OR COLD THERAPY OVER PATCH DURING TREATMENT. THE DEVICE HISTORY RECORD WAS REVIEWED, AND THE LOT OF PATCHES MET ALL RELEASED SPECIFICATIONS. THIS INCIDENT IS SIMILAR TO A COMPLAINT RECEIVED BY EMPI THAT SUGGESTS THAT THIS DEVICE MAY HAVE MALFUNCTIONED IN SUCH A WAY THAT IT COULD HAVE CONTRIBUTED TO THIS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT RECEIVED A 3RD DEGREE BURN ON TOP OF HER RIGHT FOOT WHILE USING AN EMPI HYBRESIS DEVICE; THIS WAS THE 4TH TREATMENT. THE COMPOUND USED WAS DEXAMETHASONE AT 4MG/ML, AND 1.5 ML WAS USED ON THE PATCH. THE MEDICATION WAS PLACED ON THE NEGATIVE SIDE AND SALINE WAS PLACED ON THE POSITIVE SIDE OF THE PATCH. THE MODE USED WAS "HYBRESIS", AND THE DOSE CONTROLLER WAS ON FOR 3 MINUTES, AND THE PATCH WAS WORN FOR 2 HOURS. BEFORE THE TREATMENT THE PATIENT HAD AN ULTRASOUND, AND MYOFASCIAL RELEASE OF THE LOWER LEG. A COBAN WRAP WAS USED TO WRAP OVER THE ELECTRODE, AND THE PATIENT PUT A TENNIS SHOE ON. THE PATIENT REPORTED HAVING SEVERE PAIN AND TRIED TO LEAVE THE PATCH ON AND TOLERATE THE PAIN. WHEN THE PATCH WAS REMOVED THE PATIENT NOTICED A BURN UNDER THE PATCH AND RETURNED TO THE CLINIC. SHE WAS INSTRUCTED TO FOLLOW UP WITH HER MD; SHE SAW HER MD THE NEXT DAY. THE BURN WAS NOTED AS BEING 3RD DEGREE, AND BY THE PICTURES SENT THE BURN LOOKS TO BE 1CM IN DIAMETER. WOUND WAS DEBRIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYBRESIS HYBRESIS EGJ EMPI, INC. 199589-001 83670

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other