BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYBRESIS

    MDR report key: 2853151 · Received November 30, 2012

    Report

    Report Number
    1721293-2012-00007
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    October 4, 2012
    Report Date
    November 7, 2012
    Manufacturer
    EMPI, INC.
    Product Code
    EGJ
    PMA / PMN Number
    K072946
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. THIS REPORT IS BEING SUBMITTED BECAUSE EMPI HAS RECEIVED A SIMILAR COMPLAINT THAT SUGGESTS THAT THIS DEVICE MAY HAVE MALFUNCTIONED IN SUCH A WAY THAT IT COULD HAVE CONTRIBUTED TO THIS INJURY. PATCH DISGARDED BY USER.

    Description of Event or Problem · 1

    IT WAS REPORTED TO EMPI THAT A PATIENT WAS BURNED DURING A HYBRESIS TREATMENT. THE PATIENT WAS DIAGNOSED WITH RIGHT KNEE PAIN. THE THERAPY PERFORMED BEFORE THE TREATMENT WAS MASSAGE AND THERAPEUTIC EXERCISE. THE COMPOUND USED WAS DEXAMETHAXONE, 1.4ML CONCENTRATION WAS 0.4%. THE COMPOUND WAS PLACED ON THE NEGATIVE SIDE OF THE PATCH AND SALINE WAS PLACED ON THE POSITIVE SIDE OF THE PATCH. THE HYBRESIS TREATMENT WAS FOR TWO HOURS AND IN HYBRESIS MODE. THE PATIENT NOTICED IRRITATION, BURNING AND STINGING WITHIN THE FIRST HOUR INTO THE TREATMENT, BUT LEFT THE PATCH ON FOR TWO HOURS. THE DEGREE OF BURN WAS SECOND DEGREE, AND UNDER THE BATTERY AREA OF THE PATCH. THE PATIENT DID NOT RECEIVE MEDICAL TREATMENT FOR THIS INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR