BEUDAMED
    FDA Adverse Event Summary report: N

    DURA-STICK

    MDR report key: 2192693 · Received July 21, 2011

    Report

    Report Number
    2020737-2011-00007
    Date Received
    July 21, 2011
    Date of Event
    June 22, 2011
    Report Date
    July 20, 2011
    Manufacturer
    COVIDIEN
    Product Code
    GXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL RECEIPT OF COMPLAINT REPORTS THAT ITEM BURNED PATIENT'S BACK. PATIENT WAS TREATED WITH AN LSI MACHINE AND DURA-STICK 2" SQ 40/CASE ELECTRODES. THE TREATMENT WAS COMPLETED WITHOUT INCIDENT. THE PATIENT DID NOT COMPLAIN OF ANY PAIN DURING TREATMENT AND THERE WAS NO MARK OR BLISTER. THE PATIENT CALLED BACK 1.5 DAYS LATER AND SHE SAID SHE PUT AN ICE PACK ON THE SPOT THAT WAS TREATED (REASON WHY UNKNOWN) AND A BLISTER APPEARED. IT IS UNKNOWN IF THE ICE PACK WAS WRAPPED. THE CLINICIAN SPECULATED THAT THIS MAY BE A POSSIBLE CAUSE OF THE BLISTER. THE INJURY IS IN A PERFECT CIRCLE AND THE ELECTRODES ARE SQUARE. THE CLINICIAN GAVE THE PATIENT OINTMENT AND CHANGED HER BAND-AID. THE BLISTER HAS SINCE HEALED. THE DEVICE AND ELECTRODES IN QUESTION WERE NOT RETURNED TO DJO, LLC. THE DEVICE IN QUESTION IS NOT A DJO, LLC MANUFACTURED OR DISTRIBUTED DEVICE; HOWEVER, ANY REPORT OF BURN IS CONSIDERED A SERIOUS INJURY. THIS REPORT IS BEING FILED UNDER THE DJO, LLC CORPORATE SITE NUMBER (2020737-2011-00007), HOWEVER, THE DEVICE IS NOT MANUFACTURED OR DISTRIBUTED FROM DJO, LLC CORPORATE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURA-STICK ELECTRODE GXY COVIDIEN 42183 025127

    Patients

    Seq Age Sex Outcome Treatment
    1 Other