BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM

    MDR report key: 3192024 · Received June 20, 2013

    Report

    Report Number
    2183959-2013-00866
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 FOLLOWING IMPLANTATION OF AN ELEVATE ANTERIOR A CYSTOSCOPY WAS PERFORMED AND FOUND THE DISTAL SOFT TISSUE ANCHOR OF THE ELEVATE ANTERIOR HAD "BUTTON HOLED" THE BLADDER. THE IMPLANTING PHYSICIAN CONSULTED A UROLOGIST AND REMOVED THE ELEVATE ANTERIOR GRAFT. A FOLEY CATHETER WAS PLACED PRIOR TO THE PT BEING DISCHARGED HOME. A FOLLOW UP APPOINTMENT WAS SCHEDULED TWO WEEKS POST-OPERATIVELY WITH THE PHYSICIAN. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281023 ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM SURGICAL MESH FTL AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention MINIARC PRECISE| ELEVATE POSTERIOR| IMPLANTED:| IMPLANTED: