BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURA-GUARD

    MDR report key: 2890499 · Received December 21, 2012

    Report

    Report Number
    2890499
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    December 11, 2012
    Report Date
    December 19, 2012
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    GXQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TWO (2) POST-CRANIOTOMY PATIENTS DEVELOPED POST PROCEDURAL ABSCESSES AT SURGICAL SITE WHERE DURAL PATCHES WERE USED. BOTH THE TISSUE AND PATCHES WERE REMOVED AND CULTURED IN BOTH CASES. THE TISSUE DIRECTLY UNDERNEATH THE PATCHES HAD EXTENSIVE EXUDATE. THE PATCHES THAT WERE CULTURED BOTH GREW OUT SAME ORGANISM (A BACILLUS) AND BOTH PATCHES WERE OF THE SAME LOT #. (WE ARE REASONABLY CERTAIN OF SAME LOT# BECAUSE ALL DIGITS MATCH EXCEPT THAT ONE IS MISSING A DIGIT, WHICH WE BELIEVE TO BE A TYPO IN THE OR RECORD AS THE MANUFACTOR VERIFIED THEY ONLY USE 14 DIGIT LOT #'S.) BOTH PATIENTS REQUIRED SURGERY TO REMOVE INFECTION AND PATCHES AND LONG TERM IV ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURA-GUARD DURAL REPAIR PATCH GXQ SYNOVIS SURGICAL INNOVATIONS * 5803443-1854262

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR
    2 56 YR