BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONTOUR MENISCUS ARROW

    MDR report key: 549032 · Received October 11, 2004

    Report

    Report Number
    9613278-2004-00014
    Event Type
    Other
    Date Received
    October 11, 2004
    Date of Event
    September 10, 2004
    Report Date
    October 7, 2004
    Manufacturer
    LINVATEC BIOMATERIALS LTD.
    Product Code
    MAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    INITIAL OPERATION IN 2004. POSTOPERATIVE ALLERGIC REACTION SUSPECTED, BUT CULTURE ENTEROCOCCUS FAECALIS IDENTIFIED IN WOUND. CULTURE OF UNUSED ARROW OF THE SAME LOT WAS NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR MENISCUS ARROW BIOABSORBABLE SOFT TISSUE FIXATION DEVICE MAI LINVATEC BIOMATERIALS LTD. 541113 S1334

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other