BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEVATE

    MDR report key: 2103556 · Received May 23, 2011

    Report

    Report Number
    2103556
    Event Type
    Malfunction
    Date Received
    May 23, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 20, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NH, US

    Narratives

    Description of Event or Problem · 1

    ELEVATE MESH WAS OPENED IN OR DURING PROCEDURE AND THE PHYSICIAN NOTED THAT THE PLASTIC SHEATH WAS TOO LONG AND THE INTRODUCER TIP WAS BENT. THIS KIT WAS UNABLE TO BE USED ON THE PATIENT. A NEW KIT WAS OPENED AND USED FOR THE PROCEDURE.======================MANUFACTURER RESPONSE FOR ANTERIOR AND APICAL PROLAPSE REPAIR SYSTEM, ELEVATE (PER SITE REPORTER)======================MANUFACTURER REPRESENTATIVE HAS BEEN NOTIFIED AND WILL MEET WITH PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELEVATE ANTERIOR AND APICAL PROLAPSE REPAIR SYSTEM FTL AMERICAN MEDICAL SYSTEMS, INC. * 708787007

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR