BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS MONARC SLING SYSTEM

    MDR report key: 4242725 · Received November 11, 2014

    Report

    Report Number
    2183959-2014-00513
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    April 22, 2014
    Report Date
    October 15, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    OTN
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANTED (B)(6) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A MONARC IMPLANTATION, THE PATIENT EXPERIENCED DYSPAREUNIA AND A REVISION SURGERY OCCURRED IN (B)(6) 2014 FOR "EXCISION OF MESH SLING, CYSTOURETHROSCOPY." NO ADDITIONAL PATIENT COMPLICATIONS HAVE BEEN REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725977 AMS MONARC SLING SYSTEM MESH, SURGICAL, POLYMERIC OTN AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization| R