BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGITRON 4.0 DUAL RF

    MDR report key: 6303000 · Received February 4, 2017

    Report

    Report Number
    2428235-2017-00001
    Event Type
    Injury
    Date Received
    February 4, 2017
    Date of Event
    June 16, 2016
    Report Date
    February 4, 2017
    Manufacturer
    CYNOSURE, INC. DBA ELLMAN
    Product Code
    GEI
    PMA / PMN Number
    K013255
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TREATMENT PARAMETERS PROVIDED BY PHYSICIAN ARE HIGHER THAN THE RECOMMENDED LIMITS OF OPERATION IN THE CLINICAL REFERENCE GUIDE. THIS MAY HAVE RESULTING IN THE SCARRING. SCARRING DID NOT RESOLVE SIX MONTHS AFTER THE COMPLETION OF SURGERY. PHYSICIAN DID NOT SEND DEVICE BACK TO MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    PATIENT UNDERWENT ELECTROSURGERY PROCEDURE TO TREAT SEBACEOUS HYPERPLASIA OF THE FACE, WHICH RESULTED IN GENERALIZED ERYTHEMA BUT LATER DEVELOPED DEPRESSED SCARRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85768 SURGITRON 4.0 DUAL RF SURGITRON 4.0 DUAL RF/120 IEC GEI CYNOSURE, INC. DBA ELLMAN SURGITRON 4.0 DUAL RF/120 IEC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other