BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELITE MPX

    MDR report key: 3931890 · Received June 20, 2014

    Report

    Report Number
    1222993-2014-00019
    Event Type
    Injury
    Date Received
    June 20, 2014
    Report Date
    June 20, 2014
    Product Code
    GEX
    PMA / PMN Number
    K091169
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CYNOSURE TECHNICIAN INSPECTED LASER SYSTEM AND IT IS WORKING WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    PATIENT RECEIVED A HAIR REMOVAL TREATMENT ON THEIR LEGS AND PRESENTED WITH BURNS AND REDNESS. THE PHYSICIAN PRESCRIBED SILVADENE CREAM AND REPORTED THAT THE PATIENT IS IMPROVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364047 ELITE MPX ELITE MPX GEX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention