BEUDAMED
    FDA Adverse Event Death Summary report: N

    DURAMATRIX ONLAY PLUS

    MDR report key: 15124965 · Received July 28, 2022

    Report

    Report Number
    2249852-2022-00024
    Event Type
    Death
    Date Received
    July 28, 2022
    Report Date
    October 11, 2022
    Manufacturer
    COLLAGEN MATRIX, INC
    Product Code
    GXQ
    PMA / PMN Number
    K150825
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL QUALITY CONTROL TESTING OF SAMPLES IS PENDING.

    Additional Manufacturer Narrative · 0

    ADDITIONAL QUALITY CONTROL TESTING SHOWED THE PRODUCT MET ACCEPTABLE STERILITY AND PH CRITERIA.

    Description of Event or Problem · 0

    LIMITED INFORMATION FROM A CLINICAL DATA COLLECTION SITE PROVIDED PRODUCT NAME FOR DURAMATRIX SUTURABLE, HOWEVER THE LOT NUMBER PROVIDED IS FOR DURAMATRIX ONLAY PLUS. ADDITIONAL CLARIFICATION FROM DATA COLLECTION SITE WAS REQUESTED BUT NOT PROVIDED. PRODUCT WAS USED ON PATIENT. AFTER USING THE PRODUCT, THE PATIENT DEVELOPED IVH 1 DELAY POST-OP. THE PATIENT WAS DISCHARGED TO HOSPICE AND EXPIRED 06/2021. EXACT DATE OF PATIENT DEATH WAS NOT PROVIDED. PATIENT WAS ALSO UNDERGOING CHEMO AND RADIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2922372 DURAMATRIX ONLAY PLUS COLLAGEN DURA REGENERATION MATRIX GXQ COLLAGEN MATRIX, INC 2004304022

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death| O