BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROFILE

    MDR report key: 1615602 · Received February 16, 2010

    Report

    Report Number
    2953696-2010-00005
    Event Type
    Other
    Date Received
    February 16, 2010
    Date of Event
    July 7, 2008
    Report Date
    July 8, 2008
    Manufacturer
    SCITON, INC.
    Product Code
    GEX
    PMA / PMN Number
    070388
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SCITON CLINICAL STAFF COULD NOT DETERMINE THE CAUSE OF THE PROBLEM BECAUSE THE PT DID NOT RETURN TO THE CLINIC FOR FOLLOW-UP REMEDIAL TREATMENT. NO MALFUNCTION OF THIS DEVICE WAS REPORTED WITH THIS EVENT. THE SYSTEM WAS THEN SOLD TO ANOTHER CUSTOMER WITH NO ADDITIONAL ADVERSE EVENTS.

    Description of Event or Problem · 1

    A CLINICIAN TREATING WITH MICROLASERPEEL & PROFRACTIONAL DURING A DEMO OF PROFILE SYSTEM REPORTED THAT THE PT HAD CALLED A DAY AFTER THE TREATMENT COMPLAINING ABOUT SEVERE SWELLING AROUND THE PT'S EYE WITH REPORTS OF VISION PROBLEMS AND THEN COMPLAINED ON THE PHONE ABOUT "VOMITING ALL NIGHT" ON THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFILE 2940 NM LASER GEX SCITON, INC. PROFILE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA