BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHARPLAN

    MDR report key: 268437 · Received January 19, 2000

    Report

    Report Number
    268437
    Event Type
    Injury
    Date Received
    January 19, 2000
    Date of Event
    December 10, 1999
    Report Date
    December 15, 1999
    Manufacturer
    SHARPLAN LASERS, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A LASER MICRO-LARYNGOSCOPY PT SUSTAINED A BURN TO RIGHT UPPER LIP- 2X3 MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHARPLAN CO2 LASER GEX SHARPLAN LASERS, INC. 1060 *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR