BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMOOTHBEAM LASER SYSTEM

    MDR report key: 493913 · Received October 30, 2003

    Report

    Report Number
    1218402-2003-00059
    Event Type
    Other
    Date Received
    October 30, 2003
    Date of Event
    October 1, 2003
    Report Date
    October 30, 2003
    Manufacturer
    CANDELA CORP.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT DURING THREE LASER PROCEDURES OVER THE PAST TWO MONTHS, THE CRYOGEN DID NOT SPRAY DURING 1 OR PULSES DURING THE LASER PROCEDURES. THIS COULD LEAD TO POTENTIAL SCARRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMOOTHBEAM LASER SYSTEM DERMATOLOGY LASER GEX CANDELA CORP. 9914-08-0820 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other