BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHIRON

    MDR report key: 206056 · Received January 12, 1999

    Report

    Report Number
    MW1015441
    Event Type
    Malfunction
    Date Received
    January 12, 1999
    Date of Event
    August 20, 1998
    Report Date
    January 5, 1999
    Manufacturer
    CHIRON CORP.
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING CATARACT PROCEDURE, VACUUM ON PHACO MACHINE MALFUNCTIONED. MACHINE SERVICED AND PROCEDURE COMPLETED WITHOUT ANY APPARENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHIRON PHACOTRON GOLD 10 SGS HQC CHIRON CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other