BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURAMATRIX

    MDR report key: 790702 · Received November 24, 2006

    Report

    Report Number
    2249852-2006-00001
    Event Type
    Malfunction
    Date Received
    November 24, 2006
    Date of Event
    October 20, 2006
    Report Date
    November 22, 2006
    Manufacturer
    COLLAGEN MATRIX, INC.
    Product Code
    GXQ
    PMA / PMN Number
    K040888
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S INVESTIGATION, INCLUDING REVIEW OF COMPLETE DEVICE HISTORY RECORD AND MECHANICAL TESTING OF RESERVE PRODUCT FROM THE SAME LOT, DOES NOT SUPPORT OBSERVATIONS REPORTED BY THE CUSTOMER. ALL IN-PROGRESS AND FINISHED PRODUCT TEST RESULTS FOR THIS LOT MET ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    CUSTOMER INDICATED THAT THE PRODUCT WAS UNABLE TO HOLD A SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE GXQ COLLAGEN MATRIX, INC. CDSM11 0603075022

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention