BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIGHTSHEER (ALL MODELS)

    MDR report key: 835465 · Received April 3, 2007

    Report

    Report Number
    2914019-2006-00127
    Event Type
    Other
    Date Received
    April 3, 2007
    Date of Event
    May 3, 2006
    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

    LUMENIS REGULATORY HAS NO PRIOR REPORTS OF ABSCESS INSIDE THE NOSE FOLLOWING LIGHTSHEER TREATMENT. THE LIGHTSHEER TREATMENT BEAM, WHEN APPLIED ON THE EXTERIOR OF THE NOSE, DOES NOT PENETRATE DEEPLY ENOUGH IN THE TISSUE TO EXTEND FROM THE EXTERIOR OF THE NOSE TO THE NASAL COLUMELLA, LUMENIS REGULATORY HELD A CONFERENCE CALL WITH THE CUSTOMER'S NURSE, WHO PERFORMED THE LIGHTSHEER TREATMENT. THE NURSE DESCRIBED TREATMENT TECHNIQUE THAT IS CONSISTENT WITH INSTRUCTIONS IN THE LIGHTSHEER OPERATOR MANUAL. THE TREATMENT PARAMETERS REPORTED WERE CONSISTENT WITH THE PHYSICIAN RECOMMENDED FLUENCES FOR TREATMENT WITH THE LIGHTSHEER XC DIODE LASER SYSTEM USING THE 12MM SPOT SIZE FOR THE REPORTED SKIN TYPE. LUMENIS INFORMED THE PHYSICIAN THAT, LUMENIS DOES NOT RECOMMEND TREATMENT OF THE AREA BETWEEN THE EYEBROWS WITH THE LIGHTSHEER DEVICE, DUE TO POTENTIAL OCULAR HAZARDS. PER LUMENIS RECORDS, LIGHTSHEER WAS LAST EVALUATED AT THE LUMENIS SERVICE DEPOT ON 2/16/2004. LUMENIS REGULATORY RECOMMENDED DEPOT EVALUATION OF THE LIGHTSHEER DEVICE TO ASSURE THAT IT IS OPTIMAL WORKING CONDITION. THE CUSTOMER DID NOT OBTAIN DEVICE EVALUATION. PER THE PHYSICIAN, THE REASON FOR THE ABSCESS WAS NOT KNOWN; THE PATIENT MAY HAVE PULLED A HAIR WHICH CAN CAUSE AN ABSCESS, OR PERHAPS THE ABSCESS RESULTED FROM THE NORMAL NASAL FLORS. NO FURTHER CONCLUSION CAN BE DRAWN REGARDING ROOT CAUSE.

    Description of Event or Problem · 1

    PER THE PHYSICIAN, A PATIENT ALLEGES THAT LIGHTSHEER HAIR REMOVAL TREATMENT TO THE EXTERIOR OF THE NOSE RESULTED IN AN ABSCESS ON THE PATIENT'S NASAL COLUMELLA. THE PATIENT ALSO RECEIVED LIGHTSHEER TREATMENT BETWEEN THE EYEBROWS AND REPORTED NO PROBLEMS WITH THIS OTHER TREATMENT. THE PATIENT HAD LIGHTSHEER TREATMENTS IN 2006 WITHOUT PROBLEMS. FOLLOWING THE TREATMENT, THE PATIENT DEVELOPED AN ABSCESS FOR WHICH THE PATIENT SOUGHT TREATMENT AT A LOCAL EMERGENCY ROOM, WHERE THE ABSCESS UNDERWENT RECISION, DRAINAGE AND PACKING. PER THE PHYSICIAN, THE PATIENT ALSO RECEIVED ANTIBIOTICS IN THE FORM OR ROCEPHIN INJECTION (1GM) AND ORAL CLINDAMYCIN, AS WELL AS VICODIN FOR PAIN RELIEF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSHEER (ALL MODELS) SOLID STATE ASTHETIC LASER GEX LUMENIS, INC. LIGHTSHEER XC *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention NONE REPORTED