BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANO DIAMOND DUSTED MEMBRANE SCRAPER

    MDR report key: 778830 · Received October 18, 2006

    Report

    Report Number
    778830
    Event Type
    Malfunction
    Date Received
    October 18, 2006
    Date of Event
    August 31, 2006
    Report Date
    October 18, 2006
    Manufacturer
    SYNERGETICS, INC.
    Product Code
    HNL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US

    Narratives

    Description of Event or Problem · 1

    PLASTIC TIP AT END OF TANO DIAMOND DUSTED MEMBRANE SCRAPER BROKE OFF IN THE PATIENT'S RIGHT EYE. DR. WAS ABLE TO RETRIEVE THE END WITH MINI DIAMOND FORCEPS. NO PROBLEMS NOTED. PATIENT WENT HOME LATER THAT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TANO DIAMOND DUSTED MEMBRANE SCRAPER PROBE, LASER, OCULAR HNL SYNERGETICS, INC. * 5040140

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR