BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIODESIGN DURAL GRAFT

    MDR report key: 5916930 · Received August 31, 2016

    Report

    Report Number
    5916930
    Event Type
    Malfunction
    Date Received
    August 31, 2016
    Date of Event
    August 22, 2016
    Report Date
    August 30, 2016
    Manufacturer
    COOK BIOTECH INC
    Product Code
    GXQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH A DURAL PATCH AS PART OF SURGERY APPROXIMATELY 18 MONTHS AGO. DURING A SUBSEQUENT SURGERY IT WAS NOTED THAT THERE WAS A TREMENDOUS AMOUNT OF SCAR FORMED AROUND THE PATCH. THIS MAY BE A REACTION TO THE PATCH MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569535 BIODESIGN DURAL GRAFT DURA SUBSTITUTE GXQ COOK BIOTECH INC C-DUR-4X7 LB860755

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other