BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAPULSE ENCORE AESTHETIC PACKAGE

    MDR report key: 1852483 · Received September 30, 2010

    Report

    Report Number
    2914019-2010-00045
    Event Type
    Injury
    Date Received
    September 30, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 30, 2010
    Manufacturer
    LUMENIS LTD. YOKNEAM,
    Product Code
    GEX
    PMA / PMN Number
    K022060
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF TREATMENT PARAMETERS AND POST TREATMENT PHOTOGRAPHS BY A LUMENIS MEDICAL SUBJECT MATTER EXPERT CONCLUDED THE ROOT CAUSE TO BE IMPROPER EXCESSIVE LASER EFFECT EMPLOYED ON THE PART OF THE DEVICE OPERATOR DURING TREATMENT CONTRADICTORY TO ACCEPTABLE PRACTICE. AN EXAMINATION OF THE SUBJECT DEVICE BY A LUMENIS TECHNICAL SUBJECT MATTER EXPERT CONCLUDED THE DEVICE PERFORMED TO MANUFACTURER SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT SUSTAINED HYPERTROPIC SCARRING OF THE FACE AFTER TREATMENT USING A LUMENIS ULTRAPULSE LASER. IT WAS FURTHER REPORTED THAT TEN DAYS POST TREATMENT, THE WOUNDS WERE SLOWLY HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAPULSE ENCORE AESTHETIC PACKAGE CARBON DIOXIDE SURGICAL LASER GEX LUMENIS LTD. YOKNEAM, ENCORE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other