BEUDAMED
    FDA Adverse Event Other Summary report: N

    PELVICOL

    MDR report key: 507962 · Received December 30, 2003

    Report

    Report Number
    9617613-2003-00014
    Event Type
    Other
    Date Received
    December 30, 2003
    Report Date
    December 17, 2003
    Manufacturer
    TISSUE SCIENCE LABORATORIES PLC
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other NONE NOTED