BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORGES NEOPLEX

    MDR report key: 523384 · Received March 17, 2004

    Report

    Report Number
    MW1031882
    Event Type
    Injury
    Date Received
    March 17, 2004
    Date of Event
    February 24, 2004
    Report Date
    March 1, 2004
    Manufacturer
    MENTOR-PORGES
    Product Code
    FBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 7/7/04: AS NO MORE PRECISE INFO WAS AVAILABLE, COMPANY HAS HAD TO SUPPOSE THAT THE REFERENCE OF THE DEVICE IS AG5002, THE BATCH NUMBER REMAINS UNK. UNFORTUNATELY NO DEVICE IS AVAILABLE FOR EVAL. THEREFORE COMPANY COULD NOT PERFORM ANY ANALYSIS. THIS INCIDENT IS THE FIRST ONE REPORTED WITH THE PRODUCT REFERENCED AG5002. CONCLUSION: NO EVAL. POSSIBLE.

    Description of Event or Problem · 1

    A URETHRAL DILATATION WAS ATTEMPTED USING FILIFORMS AND FOLLOWERS. AFTER SEVERAL ATTEMPTS THE LAST 2 INCHES OF THE FILIFORM FELL OUT OF THE URETHRA LEAVING THE REMAINING 10-12 INCHES INSIDE THE PT. ATTEMPTS TO RETRIEVE THE PIECE WAS UNSUCCESSFUL. PT REQUIRED A CYSTOSCOPY FOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORGES NEOPLEX FILIFORM FBW MENTOR-PORGES UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention