BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMAGE TIP

    MDR report key: 6026439 · Received October 13, 2016

    Report

    Report Number
    0002954746-2016-00041
    Event Type
    Injury
    Date Received
    October 13, 2016
    Date of Event
    August 19, 2016
    Report Date
    September 16, 2016
    Manufacturer
    SOLTA MEDICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K132431
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN RECEIVED . BASED ON THE NEW INFORMATION RECEIVED, THE EVENT IS NO LONGER CONSIDERED TO BE A SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    THE LISTED DEVICE IS NOT AVAILABLE FOR RETURN. INVESTIGATION OF THIS EVENT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION HAS BEEN RECEIVED. THOUGH SYMPTOMS WERE NOTICED THE MORNING AFTER THE TREATMENT BY THE PATIENT, SHE DID NOT ALERT THE FACILITY UNTIL 10 DAYS AFTER, WHEN SHE RETURNED FOR ANOTHER PROCEDURE. THE PATIENT WAS ADVISED TO USE BACITRACIN OINTMENT ON THE AFFECTED AREAS AND TO KEEP IT COVERED WITH SPF SUNSCREEN. THE BLISTERS ARE HEALING, BUT ARE STILL SLIGHTLY PINK A FEW MONTHS POST-TREATMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED BLISTERS AND DEMARCATIONS IN THE LEFT UPPER CHEEK AND TEMPLE POST-TREATMENT. EVENT WAS NOTED THE MORNING AFTER THE DATE OF PROCEDURE. NO OTHER PRIOR TREATMENTS HAD BEEN DONE TO THE AFFECTED AREA, AND NO SYSTEM ERRORS OCCURRED DURING THE PROCEDURE. THE HIGHEST ENERGY LEVELS USED WERE 4.0 ON THE CHEEK AND 3.0 ON THE TEMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680249 THERMAGE TIP ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORI GEI SOLTA MEDICAL, INC. TT3.00E4-1200

    Patients

    Seq Age Sex Outcome Treatment
    1 Other THERMAGE CPT SYSTEM, THERMAGE HANDPIECE