BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRAXEL RE:STORE DUAL LASER SYSTEM

    MDR report key: 1940585 · Received December 22, 2010

    Report

    Report Number
    2954746-2010-00017
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    April 28, 2010
    Report Date
    December 22, 2010
    Manufacturer
    SOLTA MEDICAL, INC.
    Product Code
    ONG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE THE DEVICE WAS PERFORMING ACCORDING TO SPECIFICATIONS, TREATMENT SETTINGS WERE VERY AGGRESSIVE LEADING TO THE COMPLICATION.

    Description of Event or Problem · 1

    ON (B)(6) 2010, SOLTA MEDICAL BECAME AWARE OF AN ADVERSE EVENT OCCURRING FOLLOWING A FRAXEL TREATMENT PERFORMED ON (B)(6) 2010. PT, WHO WAS ALSO THE DOCTOR ON THE ACCOUNT, RECEIVED FRAXEL TO HER FACE AND NECK. NECK AREA DEVELOPED CELLULITIS AND SUBSEQUENT SCARRING. SHE WAITED TILL AUGUST, WHEN IT BECAME APPARENT THAT SCARRING WAS NOT GOING AWAY, AND HAD A COUPLE OF IPL AND V-BEAM TREATMENTS TO HELP WITH THE TELANGIECTATIC APPEARANCE. CURRENTLY SHE IS COMFORTABLE WITH MANAGING THIS COMPLICATION ON HER OWN. SOLTA EMPLOYEE WHO ORIGINALLY WAS DOCUMENTING CASE LEFT SOLTA WITHOUT INSTRUCTIONS TO FOLLOW-UP OR REASSIGNMENT OF CASE. CASE RE-VIEWED ON (B)(6) 2010 WHEN REPORTABILITY WAS DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRAXEL RE:STORE DUAL LASER SYSTEM ELECTROSURGICAL UNIT AND ACCESSORIES ONG SOLTA MEDICAL, INC. MC-SYS-SR1500-D-US

    Patients

    Seq Age Sex Outcome Treatment
    1 Other