BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE

    MDR report key: 4821492 · Received June 5, 2015

    Report

    Report Number
    2183959-2015-00231
    Event Type
    Injury
    Date Received
    June 5, 2015
    Date of Event
    May 20, 2015
    Report Date
    May 21, 2015
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    OTP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN ELEVATE ANTERIOR AND A SLING IMPLANTED ON (B)(6) 2015. IT WAS REPORTED THAT THE PHYSICIAN "ACCIDENTALLY PULLED PT LEFT DISTAL ELEVATE ANCHOR FREE" WHILE ATTEMPTING TO REPOSITION THE SLING. THE PHYSICIAN "RESEATED AND PLACED EXTRA SUTURES AT DISTAL EDGE OF MESH GRAFT." THE PHYSICIAN WAS ULTIMATELY "SATISFIED" WITH MESH (RE)PLACEMENT. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. RELATED TO MANUFACTURER REPORT # 2183959-2015-00232.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363844 AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE SURGICAL MESH OTP AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R MINIARC PRECISE