BEUDAMED
    FDA Adverse Event Other Summary report: N

    CYTOPLAST RTM

    MDR report key: 3161850 · Received June 8, 2013

    Report

    Report Number
    2249852-2013-00004
    Event Type
    Other
    Date Received
    June 8, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 29, 2013
    Manufacturer
    COLLAGEN MATRIX, INC.
    Product Code
    NPL
    PMA / PMN Number
    K011695
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MEMBRANE RESORBED IN 2 WEEKS AND RESULTED IN RE-GRAFTING OF THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257715 CYTOPLAST RTM RESORBABLE COLLAGEN MEMBRANE NPL COLLAGEN MATRIX, INC. CM3040 CMN11J9

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention