BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPATOUCH PRO

    MDR report key: 1092946 · Received August 5, 2008

    Report

    Report Number
    9616256-2008-00001
    Event Type
    Injury
    Date Received
    August 5, 2008
    Date of Event
    May 21, 2008
    Report Date
    July 2, 2008
    Manufacturer
    RADIANCY INC.
    Product Code
    GEX
    PMA / PMN Number
    052442
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION WAS FIRST PRESENTED TO THE MANUFACTURER DURING A LEGAL PROCEDURE. NEITHER THE PATIENT NOR THE DOCTOR FILED ANY COMPLAINTS. THE INCIDENT IS BEING INVESTIGATED WITHIN THE MANUFACTURER'S OFFICES, AND A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION CONCLUDES.

    Description of Event or Problem · 1

    PATIENT HAS SUSTAINED BURNS ON HER FACE AND ARMS AS A RESULT OF UNDERGOING A HAIR REMOVAL PROCEDURE. THIS WAS A FIRST TIME PROCEDURE AFTER A TEST THAT WAS DONE 4 DAYS BEFORE WITH THE DEVICE ON HER LEG. DURING THE TREATMENT, THE PATIENT COMPLAINED OF DISCOMFORT AND PAIN. AFTER TREATING HER ARMS AND FACE, SHE WAS OFFERED ICE FOR HER FACE AND GIVEN A BOTTLE OF ALOE. THE PATIENT CLAIMED THAT HER SKIN CONTINUED TO FEEL A BURNING SENSATION AFTER THE ICE AND OINTMENT. THE PATIENT RETURNED TO THE OFFICE THE FOLLOWING DAY AND COMPLAINED THAT HER SKIN APPEARED BURNED AND WAS PAINFUL. THE PATIENT WAS REFERRED TO THE PHARMACIST FOR ADVICE. THE PATIENT RECEIVED ORAL STEROIDS, TOPICAL OINTMENT AND OTHER MEDICAL TREATMENT TO RESOLVE THE BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPATOUCH PRO GEX RADIANCY INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention