BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPT

    MDR report key: 1940583 · Received December 22, 2010

    Report

    Report Number
    2954746-2010-00016
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    July 2, 2010
    Report Date
    December 22, 2010
    Manufacturer
    SOLTA MEDICAL, INC.
    Product Code
    GEI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON EVALUATION OF RETURNED PAD, NO DEFECTS OR ISSUES WERE FOUND. LATEST THERMAGE TREATMENT GUIDELINES RECOMMEND PLACEMENT OF THE RETURNED PAD ON THE BACK ONLY. CLIENT INFORMED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, SOLTA MEDICAL BECAME AWARE OF AN ADVERSE EVENT OCCURRING FOLLOWING A THERMAGE TREATMENT ON (B)(6) 2010. THE PT WAS HAVING A THERMAGE TREATMENT TO THE ABDOMEN AND RECEIVED A BURN TO THE ARM WHERE THE RETURN PAD WAS LOCATED. SOLTA EMPLOYEE WHO ORIGINALLY WAS DOCUMENTING CASE LEFT SOLTA WITHOUT INSTRUCTIONS TO FOLLOW-UP OR REASSIGNMENT OF CASE. CASE REVIEWED, AND CLIENT WAS CALLED FOR FOLLOW-UP ON (B)(6) 2010 WHEN REPORTABILITY WAS DETERMINED. PT HAS HEALED WITH SMALL REPORTED SCAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CPT ELECTROSURGICAL UNIT AND ACCESSORIES GEI SOLTA MEDICAL, INC. TG-2B-UPG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other