BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS MONARC SLING SYSTEM

    MDR report key: 5574612 · Received April 13, 2016

    Report

    Report Number
    3011770902-2016-00170
    Event Type
    Malfunction
    Date Received
    April 13, 2016
    Report Date
    December 1, 2015
    Manufacturer
    ASTORA WOMEN'S HEALTH LLC
    Product Code
    OTN
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN OPENED TRAY IN THE ORIGINAL BOX WAS RETURNED. THE TRAY CONTAINED TWO NEEDLES WITH CONNECTORS ATTACHED. ONE CONNECTOR WAS BROKEN AND FORCEPS MARKS WERE PRESENT ON THE BROKEN END. THE SLING WAS ALSO RETURNED. THE SHEATH HAD BEEN REMOVED AND WAS NOT PRESENT AMONGST THE RETURNED COMPONENTS. THE SLING WAS ELONGATED (NECKING) AT SEVERAL POINTS ALONG ITS LENGTH. THE SUTURE WAS HANGING LOOSE FROM THE SLING (WHILE STILL THREADED WITHIN THE SLING).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANTATION OF MONARC, "THE TAPE DOES NOT SLIP AND WAS IN DISREPAIR." NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229337 AMS MONARC SLING SYSTEM MESH, SURGICAL, POLYMERIC OTN ASTORA WOMEN'S HEALTH LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention