BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLEMAX

    MDR report key: 2926541 · Received January 17, 2013

    Report

    Report Number
    1218402-2013-00001
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    January 5, 2013
    Report Date
    January 5, 2013
    Manufacturer
    CANDELA CORP.
    Product Code
    GEX
    PMA / PMN Number
    K112715
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LOUD EXPLOSIVE NOISE WAS HEARD COMING FROM A GENTLEMAX LASER AFTER A CANDELA FIELD SVC ENGINEER WAS DONE SERVICING THE LASER. THE FIELD SVC ENGINEER LOST HEARING FOR ABOUT 2 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25365 GENTLEMAX DERMATOLOGY LASER GEX CANDELA CORP. 9914-00-0400 NA

    Patients

    Seq Age Sex Outcome Treatment
    1