BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTRAPULSE XL 3000/5000

    MDR report key: 834634 · Received March 30, 2007

    Report

    Report Number
    2914019-2007-00008
    Event Type
    Other
    Date Received
    March 30, 2007
    Date of Event
    February 15, 2007
    Report Date
    March 30, 2007
    Manufacturer
    LUMENIS, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE PHYSICIAN, THE ROOT CAUSE OF THE INCIDENT IS PATIENT PREDISPOSITION TO KELOID SCARRING (ROOT CAUSE NOT RELATED TO THE LUMENIA DEVICE). LUMENIS REGULATORY DID NOT RECOMMEND DEVICE EVALUATION.

    Description of Event or Problem · 1

    PER THE PHYSICIAN, AT 3 DAYS POST-CO2 RESURFACING TO THE FACE THE PHYSICIAN REMOVED THE SALINE DRESSING. NO PROBLEMS NOTED. AT 4 DAYS POST-CO2 RESURFACING, THE SKIN ON THE CHEEKS BEGAN TO BREAK DOWN PER THE PHYSICIAN, THE PATIENT WAS BEGINNING TO DEVELOP KELOID SCARRING. PER THE PHYSICIAN, THE ROOT CAUSE WAS PATIENT PREDISPOSITION; PATIENT HAD A REMOTE HISTORY OF A KELOID SCAR FROM A HYSTERECTOMY APPROXIMATELY 23 YEARS AGO. THE PATIENT MAY ALSO HAVE APPLIED EXCESSIVE AQUAPHOR AFTER THE RESURFACING TREATMENT, PER THE PHYSICIAN. MEDICAL INTERVENTION CONSISTED OF SEVERAL INJECTIONS OF LOW-DOSE TRIAMELNOLONE (3MG/CC) TO THE AFFECTED AREA IN 2007. LATER PATIENT WAS GIVEN DICLOXACILLIN ANTIBIOTIC ALTHOUGH A CULTURE RESULTED NORMAL (NO INFECTION). PER REPORT FROM THE PHYSICIAN, LATER THE PATIENT WAS TREATED WITH 5-FLUOROURACIL, V-BEAM, AND STILL LAER WITH A LITTLE MORE5-FLUOROURACIL. TREATMENT. PER THE PHYSICIAN, THE CONDITION WAS COMPLETELY RESOLVED WITHOUT ANY SCARRING AS OF 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAPULSE XL 3000/5000 CARBON DIOXIDE SURGICAL LASER GEX LUMENIS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention NONE REPORTED