BEUDAMED
    FDA Adverse Event Other Summary report: N

    RCM6

    MDR report key: 3177584 · Received June 13, 2013

    Report

    Report Number
    2249852-2013-00005
    Event Type
    Other
    Date Received
    June 13, 2013
    Date of Event
    April 9, 2013
    Report Date
    May 18, 2013
    Manufacturer
    COLLAGEN MATRIX, INC.
    Product Code
    NPL
    PMA / PMN Number
    K011695
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT DEVELOPED WITH HIVES APPROXIMATELY 2 HOURS AFTER THE PROCEDURE FOR BONE GRAFTING AND MEMBRANE PLACEMENT IN AN EXTRACTION SOCKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268752 RCM6 RESORBABLE COLLAGEN MEMBRANE NPL COLLAGEN MATRIX, INC. CM3040 CMN10K11

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other ALLO-OSS CANCELLOUS PARTICULATE| PENICILLIN