BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANDELA CORP

    MDR report key: 683605 · Received February 15, 2006

    Report

    Report Number
    MW1038024
    Event Type
    Injury
    Date Received
    February 15, 2006
    Date of Event
    May 16, 2004
    Report Date
    February 6, 2006
    Manufacturer
    CANDELA CORP
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FACILITY TREATED PT'S NOSE AND RIGHT SIDE OF FACE WITH THE CANDELA GENTLE YAG LASER. TREATMENT RESULTED IN BLISTERING AND BURNS CAUSING PER. SCARS AND PERMANENT DAMAGE. CANDELA SMOOTH LASER TREATMENTS USED FOR 10 MONTH TREATMENT-DID NOT REMOVE THE SCARS OR BURN MARKS ON NOSE AND RIGHT SIDE OF FACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANDELA CORP GENTLE YAG LASER GEX CANDELA CORP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Disability