BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STIFF 25GA TANO DIAMOND DUSTED MEMBRANE SCRAPER

    MDR report key: 1379773 · Received April 27, 2009

    Report

    Report Number
    1379773
    Event Type
    Malfunction
    Date Received
    April 27, 2009
    Date of Event
    February 26, 2009
    Report Date
    April 27, 2009
    Manufacturer
    SYNERGETICS, INC.
    Product Code
    HNL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERGOING PARS PLANA VITRECTOMY WITH MEMBRANE PEEL OF THE LEFT EYE. A STIFF 25 GAUGE TANO DIAMOND DUSTED MEMBRANE SCRAPER CAME APART WHILE BEING USED DURING THE PROCEDURE. NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STIFF 25GA TANO DIAMOND DUSTED MEMBRANE SCRAPER PROBE, LACHRYMAL HNL SYNERGETICS, INC. * 8100262

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR