BEUDAMED
    FDA Adverse Event Other Summary report: N

    PELVICOL

    MDR report key: 924457 · Received September 22, 2004

    Report

    Report Number
    9617613-2004-00008
    Event Type
    Other
    Date Received
    September 22, 2004
    Report Date
    August 25, 2004
    Manufacturer
    TISSUE SCIENCE LABORATORIES, PLC
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, IT HAS NOT BEEN POSSIBLE TO PERFORM A DETAILED INVESTIGATION AS NO LOT NUMBERS ARE AVAILABLE. TSL CAN HOWEVER CONFIRM THAT THE PRODUCT IS MANUFACTURED USING A CONTROLLED AND VALIDATED MANUFACTURING PROCESS. THE PRODUCT IS TERMINALLY STERILIZED BY IRRADITION AND HAS UNDERGONE STERILIZATION VALIDATION AND DOSE AUDITS IN ACCORDANCE. ROUTINE PRODUCT BIOBURDENT IS PERFORMED TO HELP SAFEGUARD STERILITY ASSURANCE. PRODUCT AND PACKAGING INSPECTION STAGES HAVE BEEN IMPLEMENTED IN CONJUNCTION WITH A VALIDATED PROCESS AND DOCUMENTED SYSTEM TO HELP SAFEGUARD AND ASSURE PRODUCT QUALITY. THIS IS THE FIRST COMPLAINT TSL HAVE RECEIVED OF THIS NATURE AND THEREFORE, THERE IS NO INDICATION OF ANY TRENDS. TSL ARE SUBMITTING THIS REPORT AS A CONSERVATIVE APPROACH AS AT THIS STAGE WE ARE UNABLE TO DETERMINE WHETHER RE-OPERATION WAS DUE TO THE FAILURE OF THE DEVICE OR SIMPLY DUE TO FURTHER CONTINENCE TREATMENT REQUIRED.

    Description of Event or Problem · 1

    THE SURGEON REPORTED: WE BEGAN A RANDOMIZED CONTROLLED TRIAL TO COMPARE PELVICOL IMPLANT WITH OTHER TECHNIQUES FOR THE SURGICAL TREATMENT OF FEMALE STRESS URINARY INCONTINENCE. FOLLOWING AN INTERIM ANALYSIS OF THE FIRST PATIENTS TO REACH 12 MONTH FOLLOW-UP THERE WAS AN UNACCEPTABLE INCIDENT OF DELAYED FAILURE IN THE PELVICOL GROUP. PATIENTS IN THIS GROUP HAD EXPERIENCED INITIAL SATISFACTORY CURE OF THEIR INCONTINENCE WHICH SUDDENLY FAILED AFTER 6 OR MORE MONTHS. ALL OF THESE PATIENTS REQUIRED FURTHER SURGERY. THIS COMPLICATION HAS NOT OCCURRED WITH OTHER TECHNIQUES IN THE TRIAL, FOR THAT REASON RECRUITMENT TO THE PELVICOL ARM HAS NOW BEEN CLOSED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other