BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMD UNIVERSAL SLING

    MDR report key: 1865213 · Received September 29, 2010

    Report

    Report Number
    3006142121-2010-00030
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 29, 2010
    Manufacturer
    GENERIC MEDICAL DEVICES, INC.
    Product Code
    FTL
    PMA / PMN Number
    K083471
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE IS AVAILABLE. RESULTS: INVESTIGATION ONGOING. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PHYSICIAN PERFORMED TO-OI APPROACH USING REUSABLE SPIRAL TROCARS. AS PHYSICIAN PULLED THE SLEEVE THROUGH THE TISSUE, THE SLEEVE SHREDDED BROKE IN HALF. PHYSICIAN REMOVED THE SLING AND REPLACED IT 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 DEVICES, INC. 1011 23012J02

    Patients

    Seq Age Sex Outcome Treatment
    1