BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS MONARC SLING SYSTEM

    MDR report key: 5431977 · Received February 11, 2016

    Report

    Report Number
    3011770902-2016-00060
    Event Type
    Injury
    Date Received
    February 11, 2016
    Date of Event
    November 24, 2014
    Report Date
    February 8, 2016
    Manufacturer
    ASTORA WOMEN'S HEALTH LLC
    Product Code
    OTN
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A MONARC WAS IMPLANTED, THE PATIENT EXPERIENCED URINARY URGENCY, FREQUENCY AND INCOMPLETE BLADDER EMPTYING. IT WAS REPORTED THAT THE PATIENT HAD FAILED CONSERVATIVE MANAGEMENT AND THE PATIENT UNDERWENT MESH REMOVAL. UPON ENTRY INTO THE ANTERIOR VAGINAL WALL, THE MESH WAS EASILY IDENTIFIED AND REMOVED WITHOUT DIFFICULTY. CYSTOSCOPY DEMONSTRATED THAT THE URETHRA WAS INTACT. IT WAS ALSO REPORTED THAT THE DEVICE MALFUNCTIONED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87875 AMS MONARC SLING SYSTEM MESH, SURGICAL, POLYMERIC OTN ASTORA WOMEN'S HEALTH LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention