BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMAGE FLX (TG-3A) SYSTEM AND ACCESSORIES

    MDR report key: 12011719 · Received June 16, 2021

    Report

    Report Number
    3011423170-2021-00060
    Event Type
    Malfunction
    Date Received
    June 16, 2021
    Report Date
    May 19, 2021
    Manufacturer
    SOLTA MEDICAL, INC
    Product Code
    GEI
    PMA / PMN Number
    K170758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE HAS BEEN DOCUMENTED AND THE CASE HAS BEEN CLOSED DUE TO THE SUSPECT TIP BEING DISCARDED BY THE CUSTOMER. THUS, THE CUSTOMER''S ACCOUNT OF SPARKING FROM A THERMAGE FLX TIP COULD NOT BE CONFIRMED. THE TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT. THE DEVISE IS PERFORMING WITHIN ANTICIPATED RATES. NO CORRECTIVE ACTION REQUIRED. CORRECTION TO D1 BRAND NAME: THERMAGE FLX (TG-3A) SYSTEM AND ACCESSORIES.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN DISCARDED BY THE CUSTOMER; THEREFORE, THERE WILL BE NO PRODUCT EVALUATION AND THE SERIAL NUMBER IS NOT KNOWN. THE INVESTIGATION IS UNDERWAY.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED A SPARK. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907225 THERMAGE FLX (TG-3A) SYSTEM AND ACCESSORIES ELECTROSURGICAL,CUTTING & COAGULATION & ACC. GEI SOLTA MEDICAL, INC TT4.00F6-900 222

    Patients

    Seq Age Sex Outcome Treatment
    1