BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONMED

    MDR report key: 2410458 · Received January 5, 2012

    Report

    Report Number
    MW5023751
    Event Type
    Malfunction
    Date Received
    January 5, 2012
    Date of Event
    December 16, 2011
    Report Date
    January 5, 2012
    Manufacturer
    CONMED CORPORATION
    Product Code
    LKF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN REMOVING CONMED MANIPULATOR FROM PT'S VAGINA, IT CAME APART. ALL PIECES WERE LOCATED AND ACCOUNTED FOR. CURRENT LOT CODES IN HOUSE: 1111011; 1110251; 1110031; 1107251; 1108312; 1103011; 1106152; 1103291; 1107121.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED UTERINE MANIPULATOR LKF CONMED CORPORATION CURRENT LOT # LISTED

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR