BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENDURAGEN

    MDR report key: 543098 · Received September 9, 2004

    Report

    Report Number
    9617613-2004-00007
    Event Type
    Other
    Date Received
    September 9, 2004
    Report Date
    September 2, 2004
    Manufacturer
    TISSUE SCIENCE LABORATORIES, PLC
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A SLING PROCEDURE WAS CARRIED OUT TO SUSPEND THE MOUTH AND NOSE OF A PT. A COUPLE OF MONTHS LATER THE SLING HAD LOOSENED AND WAS NO LONGER SUSPENDING THE PT'S MOUTH AND NOSE. THE SURGEON RE-OPERATED IN ORDER TO REPEAT THE PROCEDURE AND NOTED THAT SOME OF THE IMPLANT APPEARED TO BE RESORBED. THE SURGEON ALSO COMMENTED THAT IT WAS HARD TO TELL EXACTLY THE CAUSE OF THE LOOSENED SLING BECAUSE THE AREA WAS SCARRED AND THE SURGEON FELT IT INAPPROPRIATE TO SPEND TIME INVESTIGATING THE CAUSE OF THE FAILED PROCEDURE.

    Description of Event or Problem · 1

    A SLING PROCEDURE WAS CARRIED OUT TO SUSPEND THE MOUTH AND NOSE OF A PT. A COUPLE OF MONTHS LATER THE SLING HAD LOOSENED AND WAS NO LONGER SUSPENDING THE PT'S MOUTH AND NOSE. THE SURGEON RE-OPERATED IN ORDER TO REPEAT THE PROCEDURE AND NOTED THAT SOME OF THE IMPLANT APPEARED TO BE RESORBED. THE SURGEON ALSO COMMENTED THAT IT WAS HARD TO TELL EXACTLY THE CAUSE OF THE LOOSENED SLING BECAUSE THE AREA WAS SCARRED AND THE SURGEON FELT IT INAPPROPRIATE TO SPEND TIME INVESTIGATING THE CAUSE OF THE FAILED PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURAGEN PORCINE DERMAL IMPLANT FTL TISSUE SCIENCE LABORATORIES, PLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention