BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT SHEER EC

    MDR report key: 384776 · Received March 22, 2002

    Report

    Report Number
    MW1024468
    Event Type
    Injury
    Date Received
    March 22, 2002
    Date of Event
    February 13, 2002
    Report Date
    March 22, 2002
    Manufacturer
    LUMENIS LASERS, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

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

    Description of Event or Problem · 2

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

    Description of Event or Problem · 3

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHT SHEER EC DIODE LASER-800 NANOMETER WAVELENGTH GEX LUMENIS LASERS, INC. EC *

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other| R
    2 52 YR Other| R
    3 27 YR Other| R