BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISP PNCL W/HLSTR BULKPAK

    MDR report key: 1709584 · Received May 26, 2010

    Report

    Report Number
    1717344-2010-00358
    Event Type
    Malfunction
    Date Received
    May 26, 2010
    Date of Event
    May 6, 2010
    Report Date
    May 13, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Removal / Correction Number
    10/2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. 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 THE PT WAS BURNED DUE TO A DEFECTIVE EXPOSED CORD. THE BURN OCCURRED ON THE LOWER ABDOMEN AND WAS AT LEAST A SECOND DEGREE BURN, WITH BLISTERS AND CHARRED AREA NOTED. THE PROCEDURE WAS PRIMARILY A BREAST AUGMENTATION FOLLOWED BY A SECONDARY TUMMY TUCK. AREA OF BURN WAS EXCISED DURING TUMMY TUCK AND THEREFORE THE PT IS UNAWARE OF THE OCCURRENCE. THE CORD WAS "BROKEN" AND THE BARE WIRE WAS SITTING UNDER A TOWEL AND TOUCHING A METAL INSTRUMENT WHICH CAUSED THE BURN WHICH WAS THEN NOTED WHEN THE TEAM CHANGED OVER FOR THE ABDOMINAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISP PNCL W/HLSTR BULKPAK ELECTROSURICAL ACCESSORY GEI COVIDIEN LP (VALLEYLAB) 170725

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK