BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMD UNIVERSAL SLING

    MDR report key: 1963560 · Received December 20, 2010

    Report

    Report Number
    3006142121-2010-00035
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 20, 2010
    Manufacturer
    GENERIC MEDICAL DEVICE, INC.
    Product Code
    FTL
    PMA / PMN Number
    K083471
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: PRODUCT NOT YET RECEIVED FOR EVALUATION. RESULTS: PRODUCT NOT YET RECEIVED. CONCLUSIONS: UNABLE TO DETERMINE AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BLUE TUBE (SLEEVE) BROKE AFTER PLACEMENT WHILE IT WAS BEING PULLED THROUGH THE TRANSOBTURATOR SPACE. PROCEDURE COMPLETED WITH 2ND GMD SLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GMD UNIVERSAL SLING FTL-SURGICAL MESH FTL GENERIC MEDICAL DEVICE, INC. 1011 23011

    Patients

    Seq Age Sex Outcome Treatment
    1