BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAPULSE ENCORE AESTHETIC PACKAGE

    MDR report key: 1760674 · Received July 14, 2010

    Report

    Report Number
    2914019-2010-00029
    Event Type
    Injury
    Date Received
    July 14, 2010
    Date of Event
    October 14, 2009
    Report Date
    July 14, 2010
    Manufacturer
    LUMENIS LTD. YOKNEAM
    Product Code
    GEX
    PMA / PMN Number
    K022060
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ON-SITE EXAMINATION OF THE SUBJECT DEVICE BY A LUMENIS TECHNICAL SUBJECT MATTER EXPERT CONCLUDED THE DEVICE PERFORMED TO MANUFACTURE SPECIFICATIONS. NO RELATED DEVICE MALFUNCTION WAS REPORTED OR OBSERVED. A REVIEW OF THE REPORTED EVENT DETAILS BY A MEDICAL SUBJECT MATTER EXPERT CONCLUDED THE PROBABLE ROOT CAUSE TO BE OPERATOR FAILURE TO FOLLOW INSTRUCTIONS WHILE PERFORMING THE PROCEDURE IN CONTRADICTION TO TRAINING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO PATIENTS SUSTAINED SCARRING AND HYPOPIGMENTATION TO THE FACE FOLLOWING TREATMENT WITH A LUMENIS ULTRAPULSE LASER.

    Additional Manufacturer Narrative · 2

    AN ON-SITE EXAMINATION OF THE SUBJECT DEVICE BY A LUMENIS TECHNICAL SUBJECT MATTER EXPERT CONCLUDED THE DEVICE PERFORMED TO MANUFACTURE SPECIFICATIONS. NO RELATED DEVICE MALFUNCTION WAS REPORTED OR OBSERVED. A REVIEW OF THE REPORTED EVENT DETAILS BY A MEDICAL SUBJECT MATTER EXPERT CONCLUDED THE PROBABLY ROOT CAUSE TO BE OPERATOR FAILURE TO FOLLOW INSTRUCTIONS WHILE PERFORMING THE PROCEDURE IN CONTRADICTION TO TRAINING.

    Description of Event or Problem · 2

    IT WAS REPORTED THAT TWO PATIENTS SUSTAINED SCARRING AND HYPOPIGMENTATION TO THE FACE FOLLOWING TREATMENT WITH A LUMENIS ULTRAPULSE LASER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Disability
    2 50 YR Disability