BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMAGE NXT

    MDR report key: 1962815 · Received January 13, 2011

    Report

    Report Number
    2954746-2011-00002
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    June 2, 2010
    Report Date
    January 12, 2011
    Manufacturer
    SOLTA MEDICAL
    Product Code
    GEI
    PMA / PMN Number
    K033942
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PAD INVOLVED IN THIS INCIDENT WAS RETURNED TO SOLTA ON (B)(4) 2010. VISUAL INSPECTION OF THE RETURNED PAD AND RETURNED PAD CABLE CONNECTOR FOUND NO DAMAGE OR INDICATION THAT THE RETURN PAD WAS INCORRECTLY USED (INSERTED INTO THE CONNECTOR OF HE RETURN PAD INCORRECTLY). NO CAUSAL LINK BETWEEN THE CONDITION OF THE RETURNED PAD AND THE PT INJURY COULD BE ESTABLISHED. THIS MDR IS FILED BEYOND THE NORMAL 30 DAY REPORTING TIMEFRAME AS PART OF SOLTA'S REVIEW OF ADVERSE EVENTS RECEIVED FROM THE LAST TWO YRS FOR REPORTABILITY.

    Description of Event or Problem · 1

    ON (B)(6) 2010, SOLTA MEDICAL, INC. WAS NOTIFIED OF AN EVENT WHERE A PT HAD BEEN BURNED IN THE AREA OF THE RETURN PAD WHILE BEING TREATED WITH A THERMAGE NXT SYSTEM. THE TREATMENT TIP USED WAS AN STC 3.0 CM TIP. DURING TREATMENT, THE PT REPORTED FEELING HEAT IN THE AREA OF THE RETURN PAD, BUT DID NOT TELL THE OPERATOR. THERE WERE NO ERROR CODES GENERATED DURING TREATMENT. THE OPERATOR STATED THEY ATTACHED THE RETURN PAD TO THE RIGHT WAIST OF THE PT IN THE SAME MANNER AS THEY USUALLY DID. THE BURN WAS NOTICED IMMEDIATELY AFTER TREATMENT WHEN THE RETURN PAD WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMAGE NXT ELECTROSURGICAL UNIT AND ACCESSORIES GEI SOLTA MEDICAL TG-2A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other