BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEVATE POSTERIOR PROLAPSE REPAIR SYS

    MDR report key: 2070982 · Received April 19, 2011

    Report

    Report Number
    2183959-2011-00132
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    April 6, 2010
    Report Date
    March 26, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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

    ON (B)(6) 2011, PATIENT REPORTED TO AMS THAT SHE HAD AN ELEVATE ANTERIOR GRAFT IMPLANTED ON (B)(6) 2010, FOR RECTOCELE REPAIR. FOLLOWING THE PROCEDURE, PATIENT REPORTS "I HAVE NOT BEEN ABLE TO EVACUATE MY STOOLS SINCE THE SURGERY, SO I HAVE BEEN MANUALLY EVACUATING." ADDITIONAL REPORTS INDICATE THAT THE PATIENT IS ALSO HAVING PAIN ASSOCIATED WITH THIS EVENT. PATIENT HAS BEEN SEEN BY NUMEROUS PHYSICIANS, AND HAS BEEN OFFERED TREATMENT WITH A COLOSTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELEVATE POSTERIOR PROLAPSE REPAIR SYS SURGICAL MESH FTL AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| S ELEVATE APICAL AND ANTERIOR PROLAPSE REPAIR SYSTEM