BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYBRESIS

    MDR report key: 1952443 · Received January 4, 2011

    Report

    Report Number
    1721293-2010-00020
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    October 20, 2010
    Report Date
    December 20, 2010
    Manufacturer
    EMPI
    Product Code
    EGJ
    PMA / PMN Number
    K072946
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATCH WAS RECEIVED FOR INVESTIGATION. THE ELECTRODE DID NOT MEET PHYSICAL OR ELECTRICAL SPECIFICATION, AS THE FLEX CIRCUIT WAS CUT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT SUFFERED A BURN UNDER THE BATTERY AREA OF THE HYBRESIS PATCH. THE PT WAS BEING TREATED FOR S/P NERVE TRANSPOSITION, USING DEXAMETHASONE 1.5CC, CONCENTRATION 4MG/ML. THE TREATMENT TIME WAS 2 HOURS. THE PT DID NOT REQUIRE ANY SPECIAL ATTENTION FOR THE BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYBRESIS HYBRESIS EGJ EMPI 199589-001 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR