BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMENIS, INC

    MDR report key: 1276468 · Received December 31, 2008

    Report

    Report Number
    2914019-2008-00071
    Event Type
    Injury
    Date Received
    December 31, 2008
    Date of Event
    December 2, 2008
    Report Date
    December 4, 2008
    Manufacturer
    LUMENIS, MFG
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH REASONABLE ATTEMPTS WERE MADE TO CONTACT, DEVICE WAS NOT RETURNED BY USER FACILITY. PROBABLE ROOT CAUSE BASED ON REPORTED CONDITIONS IS EXCESSIVE BEND FORCE DURING DEVICE USE IN CONTRADICTION TO PRODUCT LABELING. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP MDR WILL BE FILED.

    Description of Event or Problem · 1

    DURING A HOLAP PROCEDURE, THE DOCTOR RECEIVED A SMALL SECOND DEGREE BURN TO HIS RIGHT HAND. THE BURN WAS TREATED WITH TOPICAL NEOSPORIN, AND THE DOCTOR IS EXPECTED TO FULLY RECOVER WITHOUT ANY PERMANENT SCARRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMENIS, INC DUOTOME 550 MICRON FIBER GEX LUMENIS, MFG 0641-800-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention