BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYBRESIS

    MDR report key: 3786448 · Received May 2, 2014

    Report

    Report Number
    1721293-2014-00004
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    March 20, 2014
    Report Date
    April 3, 2014
    Manufacturer
    EMPI, INC
    Product Code
    EGJ
    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 LEFT SHOULDER, THE DIAGNOSIS WAS S/P RTC REPAIR; 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 EXCERCISE, MANUAL THERAPY TO INCLUDE SOFT TISSUE, JOINT MOBILIZATION AND PROM (PASSIVE RANGE OF MOTION). 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 AND THE PHYSICAL THERAPIST WAS NOTIFIED. THE BURN WAS UNDER THE NEGATIVE SIDE OF THE PATCH. THERE WAS DISCOMFORT, PAIN AND REDNESS AROUND THE AREA OF THE BURN. THE PATIENT DID NOT RECEIVE MEDICAL TREATMENT FOR THE INCIDENT. PROGRESS TOWARD RECOVERY WAS NOT IMPEDED BECAUSE OF THIS INCIDENT. THE PATIENT HAS NOT EXPERIENCED THIS TYPE OF ISSUE WITH THE HYBRESIS PATCH BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265013 HYBRESIS HYBRESIS EGJ EMPI, INC 199589-001 93821

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other