BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN DURA PRODUCT

    MDR report key: 6981335 · Received October 26, 2017

    Report

    Report Number
    2249852-2017-00019
    Event Type
    Malfunction
    Date Received
    October 26, 2017
    Date of Event
    September 13, 2017
    Report Date
    October 26, 2017
    Manufacturer
    COLLAGEN MATRIX, INC.
    Product Code
    GXQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COLLAGEN MATRIX, INC. COULD NOT VERIFY THE COMPLAINT. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS TO OBTAIN ADDITIONAL PRODUCT INFORMATION (I.E. PRODUCT REFERENCE #, LOT #, UDI), COLLAGEN MATRIX, INC. COULD NOT DETERMINE WHETHER THE COMPANY'S PRODUCT WAS USED IN THE PROCEDURE OR IF THE PRODUCT REMAINED IMPLANTED OR WAS REMOVED.

    Description of Event or Problem · 1

    A NURSE REPORTED TO THE DISTRIBUTOR THAT AN UNKNOWN DURA PRODUCT WAS USED IN A PROCEDURE PAST ITS EXPIRATION DATE OF JULY 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761625 UNKNOWN DURA PRODUCT UNKNOWN DURA PRODUCT GXQ COLLAGEN MATRIX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other