BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM

    MDR report key: 3213717 · Received July 3, 2013

    Report

    Report Number
    2183959-2013-00905
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    January 1, 2013
    Report Date
    June 5, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS EVENT, IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH AN ELEVATE ANTERIOR IN (B)(6) 2012 WITH A SUCCESSFUL OUTCOME. IN (B)(6) OF 2013, THE PATIENT WAS IN A MAJOR AUTO ACCIDENT AND PROLAPSE RECURRED IMMEDIATELY FOLLOWING THE ACCIDENT. AN ADDITIONAL ELEVATE ANTERIOR MESH WAS IMPLANTED ON (B)(6) 2013, TO TREAT THE PROLAPSE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305635 ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM SURGICAL MESH FTL AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R