BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS MINIARC PRECISE SINGLE-INCISION SLING SYSTEM

    MDR report key: 5185385 · Received October 28, 2015

    Report

    Report Number
    3011770902-2015-00001
    Event Type
    Malfunction
    Date Received
    October 28, 2015
    Date of Event
    August 27, 2015
    Report Date
    October 26, 2015
    Manufacturer
    ASTORA WOMEN'S HEALTH LLC
    Product Code
    FTL
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FDA MW REFERENCE #: MW5056039.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANTATION OF A MINIARC PRECISE THE MESH WAS NOT SECURED TO THE ANCHOR. THIS WAS NOTICED WHEN THE PHYSICIAN TRIED TO IMPLANT THE DEVICE. THE MESH BECAME DISLODGED FROM THE ANCHOR WHILE THE ANCHOR STAYED ATTACHED TO THE PATIENT. IT WAS NOTED THAT THE ANCHOR WAS "LOST IN THE OBTURATOR MUSCLE". A SECOND DEVICE WAS USED TO OBTAIN THE DESIRED RESULTS. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713599 AMS MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MESH, SURGICAL, POLYMERIC FTL ASTORA WOMEN'S HEALTH LLC

    Patients

    Seq Age Sex Outcome Treatment
    1