BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARC SLING SYSTEM

    MDR report key: 3182230 · Received June 14, 2013

    Report

    Report Number
    2183959-2013-00881
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    OTN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFO BECOME AVAILABLE REGARDING THIS EVENT IT WILL BE RE-EVALUATED AND A F/U REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PT THAT THE PT HAD A SLING IMPLANTED IN 2007 FOR VAGINAL PROLAPSE. PT THINKS THE SLING WAS A MONARC SLING SYSTEM BUT IS NOT SURE. THE PT STATED SHE IS NOW HAVING PROBLEMS WITH INCONTINENCE AND VAGINAL PROTRUSION AGAIN. THE PT REPORTED THE PHYSICIAN TOLD HER NOTHING CAN BE DONE. NO ADDITIONAL PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272058 MONARC SLING SYSTEM SURGICAL MESH OTN AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Disability