BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMD UNIVERSAL SLING

    MDR report key: 1934748 · Received November 29, 2010

    Report

    Report Number
    3006142121-2010-00031
    Event Type
    Malfunction
    Date Received
    November 29, 2010
    Date of Event
    October 21, 2010
    Report Date
    November 29, 2010
    Manufacturer
    GENERIC MEDICAL DEVICES, INC.
    Product Code
    FTL
    PMA / PMN Number
    K083471
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. INVESTIGATION IS IN PROCESS. WHEN MORE INFO IS AVAILABLE, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PROCEDURE WAS RETROPUBIC INSIDE OUT. USING 1011 SLING PHYSICIAN INSERTED THE TROCAR IN THE PT'S LEFT SIDE, THERE WAS DIFFICULTY PASSING THE TROCAR. PHYSICIAN RETRACTED THE TROCAR TO FIND THE TIP OF THE SLEEVE WAS DAMAGED. PROCEDURE COMPLETED WITH SECOND GMD 1012 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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention