BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMAGE

    MDR report key: 2358420 · Received November 29, 2011

    Report

    Report Number
    MW5023276
    Event Type
    Malfunction
    Date Received
    November 29, 2011
    Date of Event
    January 1, 2011
    Report Date
    November 29, 2011
    Manufacturer
    SOLTA MEDICAL, INC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    I AM A PHYSICIAN AND PURCHASED A MEDICAL LASER. THE LASER REQUIRES A PLASTIC TIP TO WORK. I PURCHASED SKIN TIGHTENING DEVICE FROM THERMAGE FROM (B)(6) AFTER BEING TOLD BY THE COMPANY THAT THEY WOULD TIGHTEN THE SKIN AND PTS WOULD NOT NEED SURGERY. I PURCHASED THE TIPS FOR OVER (B)(6) BUT WHEN I USED THE TIP IT DID NOT WORK AS THE COMPANY SAID IT WOULD. SOLTA MEDICAL INC INFORMED ME THAT THEY WERE IMPROVING THE PRODUCT AND ASSURED ME THAT IT WOULD WORK. HOWEVER, THE SKIN TIGHTENING TIP DID NOT WORK AS PROMISED AND SUBSEQUENTLY THE TIPS WERE DISCONTINUED. I WAS THEN LEFT WITH MEDICAL TIPS THAT DID NOT WORK AND EXPIRED EVEN THOUGH THE COMPANY NEVER DISCLOSED TO ME VERBALLY OR IN WRITING THAT THE TIPS WOULD EXPIRE. I CHECKED THE BOX ON THE TIPS AFTER SPEAKING WITH THE COMPANY AND THERE WAS A DATE BUT IT DID NOT STATE THAT IT WAS AN EXP DATE. SOLTA MEDICAL HAS REFUSED TO PROVIDE ME WITH REPLACEMENT TIPS OR A REFUND ON THE TIPS. I AM UNABLE TO PROVIDE SVS TO MY PTS AND NOW SOLTA MEDICAL INC WANTS ME TO SPEND OVER (B)(6) TO REPLACE THE DEFECTIVE EXPIRED TIPS THAT THEY NO LONGER MAKE BECAUSE THEY WERE INEFFECTIVE SO THAT I CAN TREAT MY PTS. I HAVE CALLED NUMEROUS TIMES OVER THE PAST YEAR WITH NO SUCCESS IN GETTING THEM TO RESOLVE THIS MATTER. TO MAKE MATTERS WORSE THEY WANT ME TO PURCHASE NEW EQUIPMENT FOR OVER (B)(6) JUST TO GET THEM TO COOPERATE WITH ME. I HAVE PTS THAT WANT THE PROCEDURE BUT DON'T HAVE THE PROPER TIPS TO PERFORM THE SVC. (B)(6), MD. THERMAGE TIPS AND THERAPY DATE (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMAGE THERMAGE 600 PULSES GEI SOLTA MEDICAL, INC TT0.25NB1-225 M10417

    Patients

    Seq Age Sex Outcome Treatment
    1