BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLELASE PLUS LASER SYSTEM

    MDR report key: 509760 · Received January 9, 2004

    Report

    Report Number
    1218402-2003-00079
    Event Type
    Malfunction
    Date Received
    January 9, 2004
    Date of Event
    December 5, 2003
    Report Date
    January 9, 2004
    Manufacturer
    CANDELA CORP.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    DURING A DERMATOLOGY TREATMENT IN THE CHIN/UPPER LIP AREA THE PT WAS TREATED WITH ONE LASER PULSE THAT CAUSED A BRUISE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN