BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGITRON 4.0 DUAL RF S5 IEC

    MDR report key: 7267649 · Received February 13, 2018

    Report

    Report Number
    2428235-2018-00001
    Event Type
    Injury
    Date Received
    February 13, 2018
    Date of Event
    January 15, 2018
    Report Date
    February 13, 2018
    Manufacturer
    CYNOSURE, INC. DBA ELLMAN
    Product Code
    GEI
    UDI-DI
    00841494106706
    PMA / PMN Number
    K123366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING THE RF PROCEDURE, THE PATIENT VISITED THE ER FOR POST TREATMENT CARE AND WAS EVALUATED BY A SPECIALIST. THE SPECIALIST CONCLUDED THAT THERE WAS NO RETINAL DAMAGE FOUND OR ANY VISION LOSS, RATHER THE PATIENT JUST HAD BLURRED VISION. THERE WAS NO MEDICATION PRESCRIBED BY THE SPECIALIST AND INDICATED THE PATIENT'S CONDITION SHOULD IMPROVE WITHIN A TIMEFRAME OF 2 WEEKS - 6 MONTHS. PATIENT DOES NOT HAVE A PRE-EXISTING HISTORY OF EYE RELATED ISSUES. THERE IS NO PERMANENT INJURY ANTICIPATED FROM THIS INCIDENT AS THE SPECIALIST HAD NOT SEEN ANY SIGNS OF RETINAL EYE DAMAGE AND EXPECTED A RECOVERY FOR THE PATIENT. IT WAS DEEMED INCONCLUSIVE AS TO HOW THE PATIENT EXPERIENCED THIS IMPACT.

    Description of Event or Problem · 1

    PATIENT HAD BLURRED VISION FOLLOWING AN RF TREATMENT PROCEDURE ON THE FACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109706 SURGITRON 4.0 DUAL RF S5 IEC SURGITRON 4.0 DUAL RF S5 IEC GEI CYNOSURE, INC. DBA ELLMAN 00841494106706

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other