BEUDAMED
    FDA Adverse Event Other Summary report: N

    CQUR MESH

    MDR report key: 2963912 · Received January 2, 2013

    Report

    Report Number
    1219977-2012-00225
    Event Type
    Other
    Date Received
    January 2, 2013
    Date of Event
    February 13, 2012
    Report Date
    September 24, 2012
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    FTL
    PMA / PMN Number
    K050311
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE EVALUATION WAS PERFORMED SINCE THE DEVICE WAS NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS, INCLUDING THE STERILIZATION RECORDS, INDICATED THAT THE MESH WAS PROCESSED AND INSPECTED ACCORDING TO PROCEDURES AND NO NON-CONFORMANCES WERE FOUND. PRODUCT COMPLAINTS WERE REVIEWED AND THERE WERE NO OTHER REPORTS OF PRODUCT PROBLEMS FOR THIS LOT.

    Description of Event or Problem · 1

    ALLERGIC REACTION AFTER IMPLANTATION OF CQUR MESH DEVICE. ANALYSIS UNDERGOING (WITH A SPECIALIST ON ALLERGIES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023 CQUR MESH FTL ATRIUM MEDICAL CORP. 31542 10513693

    Patients

    Seq Age Sex Outcome Treatment
    1 Other