BEUDAMED
    FDA Adverse Event Death Summary report: N

    DURAMATRIX ONLAY PLUS

    MDR report key: 6234538 · Received January 9, 2017

    Report

    Report Number
    2249852-2017-00003
    Event Type
    Death
    Date Received
    January 9, 2017
    Date of Event
    December 5, 2016
    Report Date
    January 9, 2017
    Manufacturer
    COLLAGEN MATRIX, INC.
    Product Code
    GXQ
    PMA / PMN Number
    K150825
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT COULD NOT BE CONFIRMED. UPON REQUEST OF ADDITIONAL PRODUCT INFORMATION (I.E. LOT NUMBER, REFERENCE NUMBER, UDI INFORMATION) AND PATIENT INFORMATION (I.E. REASON FOR INITIAL SURGERY, CAUSE OF DEATH) THE CLINICIAN STATED TO THE SALES REPRESENTATIVE THAT HE WILL NOT PROVIDE ANY ADDITIONAL INFORMATION. AS A RESULT COLLAGEN MATRIX, INC. CANNOT CONFIRM IF THE DURAMATRIX ONLAY PLUS PRODUCT WAS ACTUALLY USED OR WHETHER THE PRODUCT CONTRIBUTED TO THE PATIENT DEATH.

    Description of Event or Problem · 1

    THE CLINICIAN INFORMED THE SALES REPRESENTATIVE THAT A PATIENT WAS BROUGHT BACK FOR REVISION SURGERY DUE TO SUBDURAL HEMATOMA. THE CLINICIAN STATED THAT DURING THE INITIAL SURGERY A DRAIN WAS PLACED BETWEEN THE SKIN AND THE DURA MEMBRANE BUT NO FLUID HAS DRAINED. THE PATIENT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15483 DURAMATRIX ONLAY PLUS COLLAGEN DURAL REGENERATION MATRIX GXQ COLLAGEN MATRIX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death