BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLELASE

    MDR report key: 4912043 · Received July 10, 2015

    Report

    Report Number
    1218402-2015-00010
    Event Type
    Malfunction
    Date Received
    July 10, 2015
    Date of Event
    June 18, 2015
    Report Date
    July 10, 2015
    Manufacturer
    CANDELA CORP.
    Product Code
    GEX
    PMA / PMN Number
    K024260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS INSTALLED AT THE USER SITE ON 07/01/2009. THERE HAVE BEEN NO CLINICAL COMPLAINTS FROM THE USER SITE OR REGARDING THIS SPECIFIC SERIAL NUMBER SINCE THAT DATE. THE PRODUCT SERVICE HISTORY WAS REVIEWED WITH NO ISSUES FOUND. THE FIELD SERVICE ENGINEER (FSE) FOR CANDELA'S DISTRIBUTOR IN OMAN EVALUATED THE SYSTEM AND NOTED THAT THE FOOTSWITCH WAS STUCK AND THAT THE FOOTSWITCH CABLE WAS LOOSENED. THE FSE REPAIRED THE FOOTSWITCH AND THE LASER SYSTEM IS NOW OPERATING WITHIN CANDELA'S SPECIFICATION.

    Description of Event or Problem · 1

    A SITE IN (B)(6) REPORTED THAT THE LASER SYSTEM WAS DOUBLE FIRING. THERE WERE NO REPORTED INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448694 GENTLELASE DERMATOLOGY LASER GEX CANDELA CORP. 9914-00-0880 NA

    Patients

    Seq Age Sex Outcome Treatment
    1