BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTSHEER (ALL MODELS)

    MDR report key: 938207 · Received November 2, 2007

    Report

    Report Number
    2914019-2007-00046
    Event Type
    Injury
    Date Received
    November 2, 2007
    Date of Event
    October 18, 2007
    Report Date
    October 31, 2007
    Manufacturer
    RH-USA
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CLINIC HAD NOT REPORTED THIS INCIDENT AS OF 2007. THE FOLLOWING DAY, LUMENIS CALLED AND SPOKE WITH CUSTOMER WHO FELT THIS WAS NOT A SAFETY INCIDENT. CLINIC DOCTOR EXAMINED PICTURES OF PATIENT INJURIES AND DETERMINED THEY WERE FIRST DEGREE BURNS. HOWEVER, THE CLINIC HAS DETERMINED THIS IS NOT A SAFETY INCIDENT, AND FEELS THERE IS NOTHING WRONG WITH THEIR LIGHTSHEER. AN MDR IS BEING FILED DUE TO USE OF PRESCRIPTION MEDICATION, AND POSSIBILITY OF 2ND DEGREE BURNS.

    Description of Event or Problem · 1

    PATIENT CONTACTED LUMENIS REPORTING, SHE RECEIVED BURNS DURING HAIR REMOVAL TREATMENT AT AZANI MEDICAL SPA PERFORMED IN 2007. SHE SENT AN EMAIL WITH 3 PICTURES OF HER FACE AND NECK. SHE IS CLAIMING 2ND DEGREE BURNS. AZANI SPA HAS NOT REPORTED THIS INCIDENT AS OF FOUR DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSHEER (ALL MODELS) SOLID STATE AESTHETIC LASER GEX RH-USA LIGHTSHEER

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention AND SILVER NITRATE (PER PATIENT).| COOL COMPRESSES