BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI PWR DISPOSBL GRNDING PAD

    MDR report key: 2081447 · Received April 12, 2011

    Report

    Report Number
    1717344-2011-00285
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 23, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE, IT HAS NOT BEEN RECEIVED FOR EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A RF ABLATION PROCEDURE, TWO PADS WERE PLACED ON THE PATIENT'S THIGH. THE SURGEON WAS WORKING ON THE PATIENT'S LEFT ANKLE. WHEN THE PADS WERE REMOVED POST-SURGERY, IT WAS NOTED THERE WAS A SECOND DEGREE BURN THE SAME SIZE AS THE PAD ON THE PATIENT'S THIGH. THE PATIENT HAD AN ANEURYSMAL BONE CYST OF THE LEFT PROXIMAL FIBULA RESISTANT TO TRADITIONAL DOXYCYCLINE ABLATION THERAPY. THE INJURED AREA WAS DESCRIBED AS 22CM X 4.5CM, WITH A BLISTER ON THE MEDIAL SIDE OF THE AREA WHICH MEASURES 3CM X 2.5CM. THE BLISTER WAS LEFT INTACT, AND MEPILEX AG FOAM DRESSING WAS APPLIED TO THE ENTIRE BURN AREA, AND THE DRESSING WAS SECURED WITH KERLIX. THE PATIENT IS STILL BEING FOLLOWED IN THE BURN CLINIC WEEKLY WITH DAILY DRESSING CHANGES AT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI PWR DISPOSBL GRNDING PAD RF ABLATION GROUND PAD GEI COVIDIEN LP (VALLEYLAB) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR ACT1530 ELECTRODE: LOT# UNKNOWN| CTRF117 ABLATION GENERATOR: UNKNOWN S/N