BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAMATRIX ONLAY PLUS

    MDR report key: 17683330 · Received September 5, 2023

    Report

    Report Number
    2249852-2023-00016
    Event Type
    Injury
    Date Received
    September 5, 2023
    Report Date
    October 19, 2023
    Manufacturer
    COLLAGEN MATRIX, INC.
    Product Code
    GXQ
    UDI-DI
    00813954021294
    PMA / PMN Number
    K150825
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL QUALITY CONTROL TESTING OF SAMPLES IS PENDING.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    LIMITED INFORMATION WAS PROVIDED. CLINICAL DATA COLLECTION SITE REPORTED THE PATIENT UNDERWENT SURGERY FOR A RIGHT PARIETO-OCCIPITAL CRANIOTOMY. DURAMATRIX ONLAY PLUS (DMOP) WAS USED DURING SURGERY (SURGERY DATE NOT PROVIDED). PATIENT DEVELOPED PERFORATED DIVERTICULITIS 4 DAYS FOLLOWING THE INITIAL SURGERY, RESULTING IN THE NEED FOR SIGMOID COLECTOMY AND OSTOMY CREATION. THE PERFORATED DIVERTICULITIS MAY HAVE CONTRIBUTED "TO ODD PRESENTATION OF DELAYED AND DEEP WOUND INFECTION WITH MRSA" AT 7 WEEKS POST OP. ALSO AT 7 WEEKS POSTOP, PATIENT REQUIRED WOUND WASHOUT INCLUDING CRANIECTOMY AND DMOP REMOVAL FOR SUPERFICIAL AND DEEP WOULD INFECTION. THE PATIENT ALSO RECEIVED GAMMA KNIFE RADIATION ONE MONTH POSTOP. NO FURTHER EVENT INFORMATION OR INFORMATION RELATED TO PATIENT STATUS OR PATIENT OUTCOME WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1560069 DURAMATRIX ONLAY PLUS COLLAGEN DURAL REGENERATION MATRIX GXQ COLLAGEN MATRIX, INC. DMOP33 2107141022 00813954021294

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R