BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIGHTSHEER ET

    MDR report key: 1734024 · Received June 21, 2010

    Report

    Report Number
    2914019-2010-00028
    Event Type
    Other
    Date Received
    June 21, 2010
    Date of Event
    May 23, 2010
    Report Date
    June 21, 2010
    Manufacturer
    RH USA, INC.
    Product Code
    GEX
    PMA / PMN Number
    K003614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE SUBJECTED DEVICE BY A LUMENIS TECHNICAL SPECIALIST CONCLUDED THE ROOT CAUSE OF THE REPORTED EVENT TO BE DEBRIS BUILD UP ON THE TREATMENT TIP AS A RESULT OF INSUFFICIENT CLEANING BY THE USER FACILITY IN CONTRADICTION TO PRODUCT LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT SUSTAINED BLISTERS ON THE BACK AND SHOULDERS AFTER HAIR REMOVAL TREATMENT WITH A LIGHTSHEER ET LASER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSHEER ET DIODE GEX RH USA, INC. LIGHTSHEER ET NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR