BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBROSONICS PEA

    MDR report key: 43901 · Received October 21, 1996

    Report

    Report Number
    MW1010108
    Event Type
    Malfunction
    Date Received
    October 21, 1996
    Date of Event
    October 2, 1996
    Report Date
    October 7, 1996
    Manufacturer
    ALCON SURGICAL
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE DR WAS USING INSTRUMENT A SMALL PIECE CAME OUT OF THE 30 DEGREE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUBROSONICS PEA PHACOEMULSIFIER ASPIRATOR HQC ALCON SURGICAL SERIES 20000 316-1779-001

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR