BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMAGE CPT SYSTEM

    MDR report key: 7144267 · Received December 22, 2017

    Report

    Report Number
    3011423170-2017-00070
    Event Type
    Malfunction
    Date Received
    December 22, 2017
    Date of Event
    November 29, 2017
    Report Date
    December 4, 2017
    Manufacturer
    SOLTA MEDICAL,INC
    Product Code
    GEI
    PMA / PMN Number
    K132431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED TIP WAS ALREADY DISPOSED AND CAN NOT BE RETURNED TO SOLTA MEDICAL FOR EVALUATION. NO NON-CONFORMANCE OR ANOMALIES DISCOVERED DURING DHR EVALUATION. BASED ON THE CURRENT INFORMATION THE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    REPORTED THE TIP STARTED TO SPARK SOON AFTER COMMENCING THE TREATMENT. ANOTHER TIP WAS USED IN ORDER TO FINISH THE TREATMENT. THE PATIENT DIDN'T FEEL ANY DISCOMFORT WHILE GOING THROUGH THE TREATMENT WITH THE FIRST TIP. FOLLOW UP WITH THE PATIENT CONFIRMED NO ISSUES WITH THE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921811 THERMAGE CPT SYSTEM ELECTROSURGICAL,CUTTING & COAGULATION & ACC. GEI SOLTA MEDICAL,INC TTNS3.00E4 091917-001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other