BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISP HUNDSW PENICL W/HOLSTER

    MDR report key: 2971590 · Received July 11, 2007

    Report

    Report Number
    1717344-2007-00173
    Event Type
    Injury
    Date Received
    July 11, 2007
    Date of Event
    May 21, 2007
    Report Date
    June 13, 2007
    Manufacturer
    VALLEYLAB
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE MEDWATCH REPORT FROM THE HOSPITAL, AN ELECTROSURGICAL BURN RESULTED WHEN A HEMOSTAT CLAMP WHICH WAS USED TO HOLD ELECTROSURGICAL PENCIL AND PUNCTURED THE CORD CAUSING A LEAK IN THE CURRENT. THE BURN WAS EXCISED AND THE SKIN WAS STITCHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISP HUNDSW PENICL W/HOLSTER ELECTROSURGICAL ACCESSORY GEI VALLEYLAB UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention