BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIARC

    MDR report key: 5793578 · Received July 14, 2016

    Report

    Report Number
    5793578
    Event Type
    Malfunction
    Date Received
    July 14, 2016
    Date of Event
    March 8, 2016
    Report Date
    July 5, 2016
    Manufacturer
    ASTORA WOMEN'S HEALTH, LLC
    Product Code
    PAH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN THE PROCESS OF PLACING THE SLING, IT BECAME OVER STRETCHED WHILE THE SURGEON WAS TRYING TO PLACE THE SECOND ANCHOR. IT WAS REMOVED AND A SOLEX SLING WAS PLACED. PER OPERATING ROOM MANAGER, THE SLING WAS TORN/RIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448560 MINIARC MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEM PAH ASTORA WOMEN'S HEALTH, LLC 949214

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR NO