BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARC SLING SYSTEM

    MDR report key: 2890707 · Received December 26, 2012

    Report

    Report Number
    2183959-2012-03431
    Event Type
    Injury
    Date Received
    December 26, 2012
    Date of Event
    December 14, 2011
    Report Date
    December 3, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS EVENT IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2012, DURING A MONARC IMPLANT PROCEDURE, "WHEN THE DEVICE WAS INSERTED, A SMALL PIECE OF PLASTIC SLEEVE THAT PROTECTS THE MONARC HAMMOCK FABRIC, FAILED TO PEEL AWAY FROM THE DEVICE AND REMAINED ADHERENT." BECAUSE A REPLACEMENT DEVICE WAS NOT AVAILABLE AT THE TIME, "THE DEVICE REMAINED IN SITU AND THE PROCEDURE WAS COMPLETED." THE PATIENT WAS INFORMED OF THE INCIDENT AND WAS RETURNED TO THE OPERATING ROOM THE FOLLOWING DAY, ON (B)(6) 2011, "WHERE THE DEVICE (WITH THE SMALL ADHERENT PLASTIC) WAS REMOVED AND A NEW DEVICE WAS INSERTED WITHOUT DIFFICULTY." THERE WERE NO ADVERSE PATIENT OUTCOMES REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R