BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTSHEER SC

    MDR report key: 2577109 · Received May 16, 2012

    Report

    Report Number
    1720381-2012-00034
    Event Type
    Injury
    Date Received
    May 16, 2012
    Date of Event
    March 23, 2012
    Report Date
    May 16, 2012
    Manufacturer
    RH USA, INC.
    Product Code
    GEX
    PMA / PMN Number
    K001746
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A LUMENIS TECHNICAL EXPERT EXAMINED THE SUBJECT DEVICE NOTING THAT DEBRIS BUILD UP WAS OBSERVED ON THE TREATMENT TIP AS A RESULT OF INSUFFICIENT CLEANING BY THE DEVICE OPERATOR IN CONTRADICTION TO DEVICE LABELING AND COMMON MEDICAL PRACTICE. THIS IS DETERMINED TO BE THE ROOT CAUSE OF THE EVENT REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT SUSTAINED A SUPERFICIAL BURN TO THE CHEEK AREA FOLLOWING HAIR REMOVAL TREATMENT WITH A LUMENIS LIGHTSHEER SC LASER. IT WAS FURTHER REPORTED THAT NO TEST PATCH WAS PERFORMED ON THE PATIENT PRIOR TO TREATMENT. THE PATIENT IS REPORTED TO HAVE HEALED. NO INFORMATION REGARDING A REPORT OF SERIOUS INJURY OR ANY MEDICAL INTERVENTION TO PRECLUDE SERIOUS INJURY WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSHEER SC SOLID STATE AESTHETIC LASER DELIVERY DEVICE GEX RH USA, INC. LIGHTSHEER SC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other