BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDPOR IMPLANT

    MDR report key: 1515466 · Received October 22, 2009

    Report

    Report Number
    1057129-2009-00011
    Event Type
    Injury
    Date Received
    October 22, 2009
    Report Date
    October 22, 2009
    Manufacturer
    POREX SURGICAL, INC.
    Product Code
    JOF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN OUR INVESTIGATION WE HAVE MADE SEVERAL ATTEMPTS TO CONTACT THE SURGEON FOR ITEM AND LOT NUMBER INFO.

    Description of Event or Problem · 1

    THE SURGEON STATED TO A DISTRIBUTOR THAT HE PLACED MEDPOR TITAN SHEETS FOR MICROVASCULAR DECOMPRESSION IN THREE SEPARATE PTS, AND EACH DEVELOPED ASEPTIC MENINGITIS. THE SURGEON REPORTED THAT HE REMOVED THE IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDPOR IMPLANT FACIAL RECONSTRUCTION JOF POREX SURGICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other