BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 653196 · Received December 9, 2005

    Report

    Report Number
    MW1037418
    Event Type
    Malfunction
    Date Received
    December 9, 2005
    Date of Event
    December 2, 2005
    Report Date
    December 8, 2005
    Manufacturer
    SYNERGETICS, INC.
    Product Code
    HMX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TANO SCRAPER END CAME OFF DURING SURGERY OF THE EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * TANO DIAMOND DURATED MEMBRANE SCRAPPER HMX SYNERGETICS, INC. * 5090361

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other