BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS RETROARC RETROPUBIC SLING SYSTEM

    MDR report key: 5477606 · Received March 3, 2016

    Report

    Report Number
    3011770902-2016-00109
    Event Type
    Malfunction
    Date Received
    March 3, 2016
    Date of Event
    February 25, 2016
    Report Date
    March 1, 2016
    Manufacturer
    ASTORA WOMEN'S HEALTH LLC
    Product Code
    OTN
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RETROARC IMPLANT, THE TAPE AND THE SHEATH WERE "GLUED" TOGETHER. THE PHYSICIAN HAD TO DISSECT THE TAPE FROM THE SHEATH WITH A SCISSORS. IT WAS REPORTED THAT DUE TO THIS, A TENSION FREE IMPLANT WAS NOT GUARANTEED. NO FURTHER COMPLICATIONS WERE REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132895 AMS RETROARC RETROPUBIC SLING SYSTEM MESH, SURGICAL, POLYMERIC OTN ASTORA WOMEN'S HEALTH LLC

    Patients

    Seq Age Sex Outcome Treatment
    1