BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTSHEER DUET

    MDR report key: 2060231 · Received April 15, 2011

    Report

    Report Number
    1720381-2011-00011
    Event Type
    Injury
    Date Received
    April 15, 2011
    Manufacturer
    LUMENIS, INC.
    Product Code
    GEX
    PMA / PMN Number
    K053628
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REASONABLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE USER FACILITY INCLUDING TREATMENT SETTINGS AND CURRENT STATE OF THE PATIENT HOWEVER ONLY THE DESCRIPTION OF THE REPORTED EVENT WAS PROVIDED TO DETERMINE REPORTABILITY. AN ON-SITE EXAMINATION OF THE SUBJECT DEVICE BY A LUMENIS TECHNICAL SPECIALIST FOUND THAT THE SUBJECT DEVICE PERFORMED WITHIN ALLOWABLE OPERATING AND FUNCTIONAL TOLERANCES. NO RELATED DEVICE MALFUNCTION WAS OBSERVED OR REPORTED. A REVIEW OF PRODUCT LABELING AND THE REPORTED EVENT DETAILS CONCLUDED THE PROBABLE ROOT CAUSE OF THE REPORTED EVENT TO BE FAILURE TO FOLLOW DFU INSTRUCTIONS TO PERFORM A TEST PATCH PRIOR TO TREATMENT WITH A NEW DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT SUSTAINED BURNS AND SCABS TO THE NECK FOLLOWING TREATMENT WITH A LUMENIS LIGHTSHEER DUET LASER ET HANDPIECE. IT WAS FURTHER REPORTED THAT NO TEST PATCH WAS PERFORMED TO DETERMINE TREATMENT SETTINGS APPROPRIATE FOR THE PATIENT AND THAT TREATMENT SETTINGS WERE INAPPROPRIATE FOR THE PATIENT'S SKIN TYPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSHEER DUET INTENSE PULSE LIGHT DELIVERY DEVICE: DIODE GEX LUMENIS, INC. DUET N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other