BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN SYMBOTEX MESH

    MDR report key: 6125068 · Received November 23, 2016

    Report

    Report Number
    9615742-2016-00172
    Event Type
    Death
    Date Received
    November 23, 2016
    Report Date
    November 1, 2016
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6).

    Description of Event or Problem · 1

    PROCEDURE: APR STOMA. THE ISSUE REPORTED AS FOLLOWS: MESH WAS PLACED PROPHYLACTICALLY FOR POTENTIAL OF PARASTOMAL HERNIA OCCURRENCE. THE PATIENT'S MESH BECAME INFECTED. THE PATIENT WAS BROUGHT BACK TO THE THEATRE (OPERATING ROOM) FOR A WASH OUT, BUT SUBSEQUENTLY DIED. THE FOLLOWING INFORMATION WAS ALSO PROVIDED IN RELATION TO THIS COMPLAINT: REOPERATION WAS REQUIRED. CHANGED FROM ENDOSCOPIC TO OPEN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776300 UNKNOWN SYMBOTEX MESH UNKNOWN MESH FTL SOFRADIM PRODUCTION UNKSYMBOTEX

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death