BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASERSCOPE

    MDR report key: 450099 · Received March 20, 2003

    Report

    Report Number
    MW1027961
    Event Type
    Malfunction
    Date Received
    March 20, 2003
    Date of Event
    March 5, 2003
    Report Date
    March 20, 2003
    Manufacturer
    LASERSCOPE
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PDT WOULD NOT CALIBRATE. UNABLE TO RECTIFY ERROR AFTER SEVERAL ATTEMPTS. RESCHEDULED SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASERSCOPE SERIES 600 DYE LASER MODULE GEX LASERSCOPE 630XPPDT *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR