BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENDURAGEN

    MDR report key: 595914 · Received April 21, 2005

    Report

    Report Number
    9617613-2005-00012
    Event Type
    Other
    Date Received
    April 21, 2005
    Report Date
    April 20, 2005
    Manufacturer
    TISSUE SCIENCE LABORATORIES PLC
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SURGEON ASSOCIATES THIS CASE WITH A PREVIOUS CICATRICIAL DILEMMA. THE PT WHO HAD PREVIOUS SCAR TISSUE WAS ADDRESSED WITH ENDURAGEN IN THEIR EYELID BUT THE ENDURAGEN SOON BECAME INFECTED. THE SURGEON UTILIZED STEROIDS AND OTHER ANTIBIOTICS FOR NO AVAIL, AND LATER REMOVED THE IMPLANT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other