BEUDAMED
    FDA Adverse Event Other Summary report: N

    C-QUR MESH, PL, 12 X 18 (30CM X 46CM)

    MDR report key: 2474233 · Received February 28, 2012

    Report

    Report Number
    1219977-2012-00003
    Event Type
    Other
    Date Received
    February 28, 2012
    Report Date
    February 28, 2012
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    FTL
    PMA / PMN Number
    K100076
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. THE PRODUCT LOT NUMBER WAS NOT PROVIDED IN THE REPORT, THEREFORE NO LOT HISTORY RECORD REVIEW WAS CONDUCTED. BASED ON THE LIMITED INFORMATION RECEIVED, NO CONCLUSION CAN BE DRAWN AT THISTIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PATIENT HAD A HISTORY OF INFECTIONS, BUT HAD A PIECE OF COMPOSIX IMPLANTED THAT HELD, BUT RECURRED. THE SURGEON IMPLANTED A CQUR DEVICE AND LATER HAD TO REMOVE BOTH THE CQUR AND THE COMPOSIX DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-QUR MESH, PL, 12 X 18 (30CM X 46CM) FTL ATRIUM MEDICAL CORP. 31542 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1