BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYBRESIS

    MDR report key: 2480675 · Received March 6, 2012

    Report

    Report Number
    1721293-2012-00001
    Event Type
    Injury
    Date Received
    March 6, 2012
    Date of Event
    January 25, 2012
    Report Date
    February 6, 2012
    Manufacturer
    EMPI, INC.
    Product Code
    EGJ
    PMA / PMN Number
    K072946
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE WAS NOT RETURNED TO EMPI FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED IF MORE INFORMATION BECOMES AVAILABLE. A REVIEW OF THE HYBRESIS USER MANUAL WAS PERFORMED. IT STATES: "ADVISE THE PATIENT TO REPORT IMMEDIATELY ANY PAIN DURING TREATMENT. IF THE PATIENT COMPLAINS OF PAIN, PAUSE THE TREATMENT, INSPECT THE AREA UNDER THE PATCH AND MAKE NECESSARY ADJUSTMENTS (E.G. REPOSITION THE PATCH TO ENSURE FULL SKIN CONTACT, DECREASE CURRENT, ETC.) BEFORE RESUMING THE TREATMENT OR DISCONTINUE THE TREATMENT." "DO NOT TAPE OR BIND THE PATCH DURING TREATMENT." A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED, AND NO ISSUES WERE FOUND. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO EMPI: A PATIENT RECEIVED A 3RD DEGREE BURN TO HIS UPPER LEFT ARM, WITH RESULTING SCARRING. THE BURN WAS UNDER THE NEGATIVE POLARITY OF THE PATCH. THE MODE USED WAS HYBRESIS. THE PATIENT EXPERIENCED PAIN ALMOST FROM THE BEGINNING OF THE TREATMENT. A WRAP OR COVERING WAS PLACED OVER THE ELECTRODE, BUT THE TREATMENT AREA WAS NOT COMPRESSED. THE PATIENT DID RECEIVE MEDICAL TREATMENT FOR THE INCIDENT, AND PROGRESS TOWARDS RECOVERY WAS IMPEDED. AFTER THE PATCH WAS REMOVED, A BURN MARK WAS VISIBLE ON THE UNDERSIDE OF THE PATCH CLOSER TO THE NEGATIVE ELECTRODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYBRESIS HYBRESIS EGJ EMPI, INC. 199589-001 87481

    Patients

    Seq Age Sex Outcome Treatment
    1 Other