BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATRIUM C-QUR MESH

    MDR report key: 1187771 · Received October 3, 2008

    Report

    Report Number
    MW5008533
    Event Type
    Malfunction
    Date Received
    October 3, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 3, 2008
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED ALLERGIC TYPE REACTION AFTER THE ATRIUM C QUR MESH WAS APPLIED DURING A LAPAROSCOPIC INCISIONAL HERNIA REPAIR WITH MESH. PATIENT REPORTED KNEE PAIN AND RASH WHICH WAS ADDRESSED WITH PREDNISONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATRIUM C-QUR MESH C-QUR EDGE MESH FTL ATRIUM MEDICAL CORPORATION 31237

    Patients

    Seq Age Sex Outcome Treatment
    1 Other