BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYBRESIS

    MDR report key: 3785299 · Received May 1, 2014

    Report

    Report Number
    1721293-2014-00005
    Event Type
    Injury
    Date Received
    May 1, 2014
    Date of Event
    March 26, 2014
    Report Date
    April 3, 2014
    Manufacturer
    EMPI, INC
    Product Code
    GZJ
    PMA / PMN Number
    K072946
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE HYBRESIS PATCH THAT WAS USED WILL NOT BE RETURNED FOR EVALUATION. IF MORE INFORMATION BECOMES AVAILABLE THEN A FOLLOW-UP REPORT WILL BE FILED. PATCH WAS DISCARDED BY PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO EMPI THAT A PATIENT RECEIVED A 3RD DEGREE BURN DURING A HYBRESIS TREATMENT. THE INJURY WAS ON THE ANTERIOR RIGHT SHOULDER, THE DIAGNOSIS WAS RIGHT SHOULDER IMPINGEMENT, RTC TEAR; BICEPS TENDONITIS. THIS WAS THE 2ND TREATMENT. THE SKIN WAS CLEANED WITH ALCOHOL PRIOR TO THE TREATMENT. THE COMPOUND USED WAS DEXAMETHASONE AT 0.4% CONCENTRATION AND 1.5ML WAS USED ON THE NEGATIVE SIDE OF THE HYBRESIS PATCH. THE MODE WAS HYBRESIS AND THE TREATMENT WAS FOR 2 HOURS FOR 80MA MINUTE. THE THERAPY PERFORMED PRIOR TO THE TREATMENT WAS, THERAPEUTIC EXERCISE, MANUAL THERAPY PROM (PASSIVE RANGE OF MOTION) AND PRE. THE TREATMENT AREA WAS NOT COMPRESSED AND THERE WAS NO WRAP OR COVERING ON THE ELECTRODE. THE PATIENT NOTICED THE BURN UPON REMOVAL OF THE PATCH. THE PHYSICAL THERAPIST WAS NOTIFIED ONE WEEK AFTER THE TREATMENT. THE BURN WAS UNDER THE NEGATIVE SIDE OF THE PATCH. THERE WAS PAIN FROM THE BURN, OTHERWISE IMPROVEMENT IN DISTAL BICEPS. THE PATIENT DID NOT RECEIVE MEDICAL TREATMENT FOR THE INCIDENT. PROGRESS TOWARD RECOVERY WAS NOT IMPEDED BECAUSE OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261303 HYBRESIS HYBRESIS GZJ EMPI, INC 199589-001 93821

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other