BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAGEN DENTAL MEMBRANE - CONFORMABLE II

    MDR report key: 5685922 · Received May 27, 2016

    Report

    Report Number
    2249852-2016-00012
    Event Type
    Malfunction
    Date Received
    May 27, 2016
    Report Date
    April 27, 2016
    Manufacturer
    COLLAGEN MATRIX, INC.
    Product Code
    NPL
    PMA / PMN Number
    K062881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THE DATE OF THIS REPORT, THE DEVICE CURRENTLY UNDER EVALUATION. A FOLLOW-UP REPORT WILL BE FILED UPON CONCLUSION OF THE INVESTIGATION. EVALUATION ONGOING, FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    ON APRIL 27TH, 2016 COLLAGEN MATRIX, INC. WAS NOTIFIED THAT FOREIGN MATTER WAS DISCOVERED INSIDE THE STERILE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341367 COLLAGEN DENTAL MEMBRANE - CONFORMABLE II NPL COLLAGEN MATRIX, INC. PRCMA15E1

    Patients

    Seq Age Sex Outcome Treatment
    1