BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMD UNIVERSAL SLING

    MDR report key: 1959174 · Received December 17, 2010

    Report

    Report Number
    3006142121-2010-00033
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 22, 2010
    Report Date
    December 17, 2010
    Manufacturer
    GENERIC MEDICAL DEVICES, INC.
    Product Code
    FTL
    PMA / PMN Number
    K083471
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - PRODUCT UNAVAILABLE FOR RETURN. DESCRIPTION OF EVENT UNCLEAR. RESULTS - UNK. CONCLUSIONS - UNABLE TO DETERMINE RELATIONSHIP BETWEEN DEVICE AND CAUSE FOR THIS EVENT AT THIS TIME. SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PHYSICIAN PERFORMED A TO-OI APPROACH. PHYSICIAN ATTEMPTED TO IMPLANT GMD SLING AND THERE WAS A PROBLEM WITH CONNECTING ONE SIDE (SIDE NOT REPORTED) AND COMPLETED THE SURGERY BY IMPLANTING ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GMD UNIVERSAL SLING FTL-SURGICAL MESH FTL GENERIC MEDICAL DEVICES, INC. 1011 22860J06

    Patients

    Seq Age Sex Outcome Treatment
    1 Other