BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS MONARC SLING SYSTEM

    MDR report key: 5444983 · Received February 18, 2016

    Report

    Report Number
    3011770902-2016-00070
    Event Type
    Injury
    Date Received
    February 18, 2016
    Date of Event
    April 24, 2006
    Report Date
    February 10, 2016
    Manufacturer
    ASTORA WOMEN'S HEALTH LLC
    Product Code
    OTN
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A MONARC WAS IMPLANTED, THE PATIENT EXPERIENCED MESH EXTRUSION INTO THE VAGINA, WHICH CAUSED PAIN. THE MESH WAS PARTIALLY EXCISED ON (B)(6) 2015. THE EVENT WAS CONSIDERED RESOLVED. ADDITIONAL INFORMATION WAS REQUESTED, IF RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101650 AMS MONARC SLING SYSTEM MESH, SURGICAL, POLYMERIC OTN ASTORA WOMEN'S HEALTH LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention