BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPRODRAIN - 7MM

    MDR report key: 1904226 · Received November 15, 2010

    Report

    Report Number
    MW5018236
    Event Type
    Malfunction
    Date Received
    November 15, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 15, 2010
    Manufacturer
    SURGIMARK, INC.
    Product Code
    JOL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AS SURGEON TRIED TO PULL DRAIN THROUGH PORT HOLE, THE END PIECE BROKE OFF IN TWO PIECES. BROKEN PIECES WERE RETRIEVED AND BROUGHT UP TROUGH PORT. NO PIECES LEFT IN PT. DATES OF USE: (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: GALLBLADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAPRODRAIN - 7MM LAPAROSCOPIC WOUND DRAIN W/DRAIN TOW INSERTION SYSTEM JOL SURGIMARK, INC. LD-2007-JP07 394128

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR