BEUDAMED
    FDA Adverse Event Death Summary report: N

    DURAMATRIX SUTURABLE

    MDR report key: 15125095 · Received July 28, 2022

    Report

    Report Number
    2249852-2022-00025
    Event Type
    Death
    Date Received
    July 28, 2022
    Report Date
    October 11, 2022
    Manufacturer
    COLLAGEN MATRIX, INC
    Product Code
    GXQ
    PMA / PMN Number
    K141608
    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

    CLINICAL DATA COLLECTION SITE REPORTED DURAMATRIX SUTURABLE WAS USED ON A PATIENT. THE CIRCUMSTANCES UNDER WHICH THE PRODUCT WAS USED WAS NOT SPECIFIED. SUPERFICIAL WOUND DEBRIDEMENT WAS PERFORMED. THE PATIENT DEVELOPED A HEMATOMA AND INFECTION AT THE INCISION SITE. PATIENT WAS ALSO UNDERGOING RADIATION THERAPY AND HAD GLIOBLASTOMA. PATIENT EXPIRED. EXACT DATE OF PATIENT DEATH WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2458169 DURAMATRIX SUTURABLE COLLAGEN DURA MEMBRANE GXQ COLLAGEN MATRIX, INC 2003191121

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| D