BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-QUR MOSAIC

    MDR report key: 6348758 · Received February 22, 2017

    Report

    Report Number
    6348758
    Event Type
    Malfunction
    Date Received
    February 22, 2017
    Date of Event
    January 6, 2017
    Report Date
    February 13, 2017
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN THE SURGEON TRIED TO PASS A SUTURE THROUGH THE MIDDLE OF THE PRODUCT, THE PRODUCT HAD A HOLE TORN IN IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133015 C-QUR MOSAIC MESH, SURGICAL, POLYMERIC FTL ATRIUM MEDICAL CORPORATION 31106 407066

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR NO