BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS MONARC SLING SYSTEM

    MDR report key: 5470413 · Received March 1, 2016

    Report

    Report Number
    3011770902-2016-00094
    Event Type
    Malfunction
    Date Received
    March 1, 2016
    Date of Event
    February 25, 2016
    Report Date
    February 25, 2016
    Manufacturer
    ASTORA WOMEN'S HEALTH LLC
    Product Code
    OTN
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, THE MONARC SLING SHEATHS WOULD NOT COME OFF AFTER IMPLANTATION WITHOUT EXTREME DIFFICULTY. AFTER THE MONARC WAS PLACED, THE SLING WAS CUT BELOW THE BLUE DOT, AND THE MESH SLEEVE WAS TRIED TO BE REMOVED WITH A HAEMOSTAT BUT WOULD NOT COME OFF. THE PHYSICIAN THEN TRIED THE OTHER SIDE AND EXPERIENCED THE SAME DIFFICULTY. THE TENSIONING SUTURE THEN BROKE AND THE MESH BECAME STRETCHED WHILE TRYING TO REMOVE THE PLASTIC SHEATHS. THE PHYSICIAN DECIDED TO REMOVE THE WHOLE DEVICE AND USED ANOTHER MONARC WITH NO PROBLEM. NO FURTHER COMPLICATIONS WERE NOTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128186 AMS MONARC SLING SYSTEM MESH, SURGICAL, POLYMERIC OTN ASTORA WOMEN'S HEALTH LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention