BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STOP

    MDR report key: 2897844 · Received December 11, 2012

    Report

    Report Number
    2897844
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Date of Event
    November 15, 2012
    Report Date
    December 11, 2012
    Manufacturer
    CL MEDICAL INC.
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING TRANSOBTURATOR TAPE MID URETHRAL SLING PLACEMENT, THE COUPLING FOR THE I-STOP GRAFT BROKE OFF WHEN THE SURGEON WAS PULLING IT THROUGH THE TRANSVAGINAL PATH TO THE GROIN. ANOTHER I-STOP WAS NOT AVAILABLE, SO THE SURGEON UTILIZED AN OBTYRX TOT SLING IN PLACE TO DO THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT, AND SHE TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STOP PELVIC SLING FTL CL MEDICAL INC. IS-6 IS-12-23

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR