BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RCT RESORBABLE COLLAGEN TAPE

    MDR report key: 7054338 · Received November 22, 2017

    Report

    Report Number
    2249852-2017-00021
    Event Type
    Injury
    Date Received
    November 22, 2017
    Date of Event
    October 19, 2017
    Report Date
    November 22, 2017
    Manufacturer
    COLLAGEN MATRIX, INC.
    Product Code
    LYC
    PMA / PMN Number
    K033729
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COLLAGEN MATRIX, INC. WAS INFORMED THAT THE PRODUCT RCT RESORBABLE COLLAGEN TAPE WAS USED PAST THE PRODUCT'S ESTABLISHED SHELF LIFE. COLLAGEN MATRIX, INC. CANNOT GUARANTEE PRODUCT PERFORMANCE OR STERILITY PAST THE ESTABLISHED SHELF LIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832915 RCT RESORBABLE COLLAGEN TAPE COLLAGEN DENTAL WOUND DRESSING LYC COLLAGEN MATRIX, INC. DWTN12M1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other