BEUDAMED
    FDA Adverse Event Other Summary report: N

    APOGEE 9300

    MDR report key: 414279 · Received August 19, 2002

    Report

    Report Number
    1222993-2002-00001
    Event Type
    Other
    Date Received
    August 19, 2002
    Date of Event
    April 23, 2002
    Report Date
    August 15, 2002
    Manufacturer
    CYNOSURE, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT TYPE 3 SKIN) WAS TREATED FOR HAIR REMOVAL WITH A CYNOSURE APOGEE 9300 LASER 2002. TREATED AREAS WERE LOWER LEG AND BIKINI. TREATMENT PARAMETERS WERE 14J/CM2, 20MS PULSE DURATION WITH A SCANNER. "HYPERPIGMENTED DOTS AFTER RX, BLISTERED NEXT DAY, BOTH LEGS"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APOGEE 9300 SOLID STATE ALEXANDRITE LASER GEX CYNOSURE, INC. 105-0019-000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other SMARTCOOL CHILLER (FROM 2002(CONTIN).