BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUANTUM

    MDR report key: 712823 · Received May 11, 2006

    Report

    Report Number
    2914019-2006-00043
    Event Type
    Injury
    Date Received
    May 11, 2006
    Date of Event
    March 24, 2006
    Report Date
    May 11, 2006
    Manufacturer
    LUMENIS, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REQUESTED SERVICE ON 03/17/2006 FOR A PROBLEM WITH THE TOUCHSCREEN OF THE QUANTUM SR (PRODUCT COMPLAINT). LUMENIS RECOMMENDED A SERVICE CALL AND THE CUSTOMER DEFERRED RETURNING THE LETTER ON INTENT NECESSARY FOR THE BILLABLE SERVICE. ON 03/28/2006 THE CUSTOMER REPORTED THAT 2 PT HAD BEEN BURNED AND BLISTERED WITH REDNESS AND REQUESTED SERVICE TO EVALUATE THE SYSTEM. LUMENIS MADE MULTIPLE REQUEST FOR PT AND INCIDENT DETAILS FOR INVESTIGATION, AND ONLY LIMITED DETAILS WERE PROVIDED. LUMENIS REGULATORY WAS INFORMED ON 05/11/2006 THAT ONE OF THE PT IS A FEMALE; ADDITIONAL DETAILS WERE REQUESTED BY REGULATORY ON 05/11/2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM COMBINATION INTENSE PULSE LIGHT DEVICE AND SOLID STATE LASER GEX LUMENIS, INC. GAL3696000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention