BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTSHEER XC

    MDR report key: 1696666 · Received May 20, 2010

    Report

    Report Number
    2914019-2010-00025
    Event Type
    Injury
    Date Received
    May 20, 2010
    Date of Event
    April 6, 2010
    Report Date
    May 21, 2010
    Manufacturer
    RH USA, INC.
    Product Code
    GEX
    PMA / PMN Number
    K003614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE REPORTED EVENT DETAILS BY A LUMENIS MEDICAL SUBJECT MATTER EXPERT CONCLUDED THE PROBABLE ROOT CAUSE OF THE REPORTED EVENTS TO BE FAILURE ON THE PART OF THE DEVICE OPERATOR TO CLEAN THE TREATMENT TIP ACCORDING TO PRODUCT LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOUR PTS SUSTAINED BURNS AFTER HAIR REMOVAL TREATMENT WITH A LIGHTSHEER XC LASER. IT WAS FURTHER REPORTED THAT THE PTS HAD HEALED WITH NO PERMANENT IMPAIRMENT, AND NO MEDICAL INTERVENTION REQUIRED TO PRECLUDE PERMANENT IMPAIRMENT.

    Additional Manufacturer Narrative · 2

    A REVIEW OF THE REPORTED EVENT DETAILS BY A LUMENIS MEDICAL SUBJECT MATTER EXPERT CONCLUDED THE PROBABLE ROOT CAUSE OF THE REPORTED EVENTS TO BE FAILURE ON THE PART OF THE DEVICE OPERATOR TO CLEAN THE TREATMENT TIP ACCORDING TO PRODUCT LABELING.

    Description of Event or Problem · 2

    IT WAS REPORTED THAT FOUR PTS SUSTAINED BURNS AFTER HAIR REMOVAL TREATMENT WITH A LIGHTSHEER XC LASER. IT WAS FURTHER REPORTED THAT THE PTS HAD HEALED WITH NO PERMANENT IMPAIRMENT AND NO MEDICAL INTERVENTION REQUIRED TO PRECLUDE PERMANENT IMPAIRMENT. DATE OF EVENT FOR 2ND PT IS (B) (6) 2010.

    Additional Manufacturer Narrative · 3

    A REVIEW OF THE REPORTED EVENT DETAILS BY A LUMENIS MEDICAL SUBJECT MATTER EXPERT CONCLUDED THE PROBABLE ROOT CAUSE OF THE REPORTED EVENTS TO BE FAILURE ON THE PART OF THE DEVICE OPERATOR TO CLEAN THE TREATMENT TIP ACCORDING TO PRODUCT LABELING.

    Description of Event or Problem · 3

    IT WAS REPORTED THAT FOUR PTS SUSTAINED BURNS AFTER HAIR REMOVAL TREATMENT WITH A LIGHTSHEER XC LASER. IT WAS FURTHER REPORTED THAT THE PTS HAD HEALED WITH NO PERMANENT IMPAIRMENT AND NO MEDICAL INTERVENTION REQUIRED TO PRECLUDE PERMANENT IMPAIRMENT. DATE OF EVENT FOR 3RD PT IS (B) (6) 2010.

    Additional Manufacturer Narrative · 4

    A REVIEW OF THE REPORTED EVENT DETAILS BY A LUMENIS MEDICAL SUBJECT MATTER EXPERT CONCLUDED THE PROBABLE ROOT CAUSE OF THE REPORTED EVENTS TO BE FAILURE ON THE PART OF THE DEVICE OPERATOR TO CLEAN THE TREATMENT TIP ACCORDING TO PRODUCT LABELING.

    Description of Event or Problem · 4

    IT WAS REPORTED THAT FOUR PTS SUSTAINED BURNS AFTER HAIR REMOVAL TREATMENT WITH A LIGHTSHEER XC LASER. IT WAS FURTHER REPORTED THAT THE PTS HAD HEALED WITH NO PERMANENT IMPAIRMENT AND NO MEDICAL INTERVENTION REQUIRED TO PRECLUDE PERMANENT IMPAIRMENT. DATE OF EVENT FOR 4TH PT IS (B) (6) 2010.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other
    2 22 YR Other
    3 24 YR Other
    4 32 YR