BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLELASE PLUS

    MDR report key: 528734 · Received February 25, 2004

    Report

    Report Number
    1218402-2003-00081
    Event Type
    Malfunction
    Date Received
    February 25, 2004
    Date of Event
    May 13, 2003
    Report Date
    February 23, 2004
    Manufacturer
    CANDELA CORP.
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A LASER HAIR REMOVAL PROCEDURE WAS PERFORMED ON A PT'S LEGS. TREATMENT RESULTED IN HYPERPIGMENTATION THAT IS CLEARING. IT WAS REPORTED AS HIGH ENERGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENTLELASE PLUS DERMATOLOGY LASER GEX CANDELA CORP. 9914-00-2120 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other