BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE

    MDR report key: 5772918 · Received July 6, 2016

    Report

    Report Number
    3011770902-2016-00290
    Event Type
    Malfunction
    Date Received
    July 6, 2016
    Date of Event
    December 29, 2010
    Report Date
    July 1, 2016
    Manufacturer
    ASTORA WOMEN'S HEALTH LLC
    Product Code
    OTP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING THE IMPLANTATION OF AN ELEVATE ANTERIOR, THE PATIENT HAD HER GRAFT REMOVED DURING THE SURGERY AS IT DID NOT HOLD TENSION. A SECOND ELEVATE ANTERIOR WAS OPENED AND PLACED. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED PAIN AND PUDENDAL NERVE DAMAGE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT. RELATED TO MANUFACTURER REPORT #: 3011770902-2016-00289.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426808 AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE SURGICAL MESH OTP ASTORA WOMEN'S HEALTH LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ELEVATE ANTERIOR