BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENDURAGEN

    MDR report key: 590450 · Received April 7, 2005

    Report

    Report Number
    9617613-2005-00011
    Event Type
    Other
    Date Received
    April 7, 2005
    Report Date
    April 7, 2005
    Manufacturer
    TISSUE SCIENCE LABORATORIES, PLC
    Product Code
    FTM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT HAD A PYROGENIC GRANULOMA TYPE REACTION A FEW WEEKS AFTER SURGERY. THE DOCTOR PLACED THE PT ON STEROIDS BUT THE PT DID NOT RESPOND TO THE STEROIDS AND AS THE SITUATION WAS NOT GETTING ANY BETTER, THE DOCTOR DECIDED TO REMOVE THE IMPLANT. ON REMOVAL, THE DOCTOR COMMENTED THAT THE IMPLANT WAS NOT INFECTED BUT HAD CHRONIC IRRITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURAGEN PORCINE DERMAL IMPLANT FTM TISSUE SCIENCE LABORATORIES, PLC UNK 04B04-1

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other