BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURAMATRIX SUTURABLE

    MDR report key: 10822629 · Received November 11, 2020

    Report

    Report Number
    2249852-2020-00011
    Event Type
    Malfunction
    Date Received
    November 11, 2020
    Date of Event
    October 6, 2020
    Report Date
    November 11, 2020
    Manufacturer
    COLLAGEN MATRIX, INC.
    Product Code
    GXQ
    UDI-DI
    00813954020419
    PMA / PMN Number
    K141608
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT WAS TREATED FOR A CHIARI MALFORMATION. THE PATIENT WAS IMPLANTED WITH DURAMATRIX SUTURABLE AND DURASEAL EXACT WAS SPRAYED OVER IT. THE PATIENT THEN HAD A FALL AND THE PHYSICIAN HAD TO DO A 2ND SURGERY DUE TO A CSF LEAK. THE PHYSICIAN STATED THAT THE DURA PATCH FELT LIKE JELLY IN THE MIDDLE BUT WAS STILL SUTURED ALL THE WAY AROUND. THE DURA PRODUCT WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1290394 DURAMATRIX SUTURABLE COLLAGEN DURA MEMBRANE GXQ COLLAGEN MATRIX, INC. DMS33 1902281121 00813954020419

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention