BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIGHTSHEER (ALL MODELS)

    MDR report key: 808806 · Received January 19, 2007

    Report

    Report Number
    2914019-2006-00118
    Event Type
    Other
    Date Received
    January 19, 2007
    Date of Event
    December 13, 2006
    Report Date
    January 19, 2007
    Manufacturer
    LUMENIS, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    HYDRADENITIS SUPPURATIVA IS A FOLLICULAR DISORDER OF THE SKIN (WHO ICD-10). AS OF 1/18/2007, DEPOT SERVICE EVALUATION OF THE CUSTOMER'S LIGHTSHEER DEVICE IS IN PROCESS. A FOLLOW-UP MEDWATCH REPORT WILL BE FILED WITH DEVICE EVALUATION AND ROOT CAUSE ANALYSIS.

    Description of Event or Problem · 1

    PER THE PHYSICIAN, A PATIENT WHO UNDERWENT THE 4TH LIGHTSHEER HAIR REMOVAL TREATMENT TO THE AXILLA IN 2006, SUBSEQUENTLY PRESENTED WITH ACUTE HYDRADENITIS SUPPURATIVE FOR WHICH ORAL ANTIBIOTIC (AMOXICILLIN 500 MG TID#20) WAS PRESCRIBED. PER THE PHYSICIAN, THE PATIENT HAD VERY REDDENED BOILS (PAINFUL NODULES ABOUT 1 CM HIGH) IN THE AXILLA, LEFT GREATER THAN RIGHT. THE BOILS RANGED IN SURFACE AREA FROM THE SIZE OF A PEA TO THE SIZE OF A LIMA BEAN, PER THE PHYSICIAN. PER THE PHYSICIAN, NO LESIONS WERE EVIDENT IMMEDIATELY AFTER THE LIGHTSHEER HAIR REMOVAL TREATMENT. NO PROBLEM WAS REPORTED REGARDING THE TREATMENTS PERFORMED ON THE EVENT, TO THE PATIENT'S LOWER ABDOMEN AND BIKINI AREA. SIX DAYS LATER, THE NODULES IN THE RIGHT AXILLA WERE SUBSIDING AND THE NODULES IN THE LEFT AXILLA WERE STILL PAINFUL. LUMENIS RECOMMENDED TO SUSPEND USE OF THE DEVICE PENDING DEPOT SERVICE EVALUATION; CUSTOMER WAS PROVIDED WITH A DEMO SYSTEM DURING SERVICING OF THE CUSTOMER DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other NONE USED PER THE PHYSICIAN