BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENDURAGEN

    MDR report key: 689020 · Received March 13, 2006

    Report

    Report Number
    9617613-2006-00003
    Event Type
    Other
    Date Received
    March 13, 2006
    Report Date
    March 13, 2006
    Manufacturer
    TISSUE SCIENCE LABORATORIES, PLC
    Product Code
    FTM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT RECEIVED AN ENDURAGEN IMPLANT FOR LIP AUGMENTATION. TWO WEEKS AFTER IMPLANTATION, THE PT DEVELOPED AN INFECTION AND THE IMPLANT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURAGEN PORCINE DERMAL IMPLANT FTM TISSUE SCIENCE LABORATORIES, PLC NA 04B11-1

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other