BEUDAMED
    FDA Adverse Event Other Summary report: N

    GENTLE YAG

    MDR report key: 681313 · Received March 1, 2006

    Report

    Report Number
    1218402-2006-00013
    Event Type
    Other
    Date Received
    March 1, 2006
    Date of Event
    July 2, 2004
    Report Date
    February 27, 2006
    Manufacturer
    CANDELA CORP.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A CUSTOMER PRE-SALE EVALUATION PERIOD, THE DR TREATED AN EMPLOYEE WITH A DEMONSTRATION VPYAG LASER. THE DR TREATED TELANGIECTASIA ON THE INSIDE THIGH OF THE EMPLOYE WITH A 3MM DELIVERY SYSTEM AT 240-280 J/CM2 AND A PULSE WIDTH OF 60MS. ONE OR TWO OF THE DELIVERED LASER PULSES RESULTED IN BLISTERING AND AN ULCERATED SCAR APPROX 8MM IN DIAMETER. OTHER LASER PULSES HAD NO ADVERSE EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENTLE YAG DERMATOLOGY LASER GEX CANDELA CORP. 9914-00-0950 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other