BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIPOSONIX SYSTEM

    MDR report key: 3925965 · Received June 30, 2014

    Report

    Report Number
    3004106598-2014-00004
    Event Type
    Injury
    Date Received
    June 30, 2014
    Report Date
    May 29, 2014
    Manufacturer
    SOLTA MEDICAL INC.
    Product Code
    OHV
    PMA / PMN Number
    K112626
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PHOTOS WERE PROVIDED, HOWEVER THE PHYSICIAN REPORTED THE PATIENT WAS A GOOD CANDIDATE, THERE WAS AT LEAST 1CM OF SUBCUTANEOUS ADIPOSE TISSUE BEYOND THE FOCAL DEPTH OF TREATMENT. INFORMATION REGARDING THE MAKE-UP OF THE FLUID WAS REPORTED. THE MANUFACTURER IS ATTEMPTING TO CONNECT THE SYSTEM TO THE INTERNET TO OBTAIN THE SYSTEM LOG FILES FOR EVALUATION. THE MOST FREQUENTLY REPORTED SIDE EFFECTS AFTER LIPOSONIX TREATMENT, AS RECOMMENDED, ARE PAIN (DISCOMFORT), ECCHYMOSIS, ERYTHEMA, AND EDEMA, WHICH ARE GENERALLY DESCRIBED (OR RATED) AS MILD.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT TWO WEEKS POST HIGH INTENSITY FREQUENCY ULTRASOUND HIFU TREATMENT, PERFORMED ON THE ABDOMEN THE PATIENT DEVELOPED BRUISING/HEMATOMA (HYPERPIGMENTED AREA A LITTLE LARGER THAN A QUARTER DOLLAR SIZE), SORENESS TO TOUCH AND FLUID BUILD-UP BELOW THE UMBILICUS. AN ULTRASOUND OF THE ABDOMEN WAS PERFORMED CONFIRMING A SMALL 2CM POCKET OF FLUID VISUALIZED BELOW THE AREA OF PAIN AND SKIN CHANGE. ANTIBIOTIC WAS PRESCRIBED SECONDARY TO THE SIGNS AND SYMPTOMS PATIENT PRESENTED WITH, INITIALLY TREATED WITH CEPHALEXIN (500MG QID X 7 DAYS). THE PATIENT HAS SOUGHT FUTURE CARE FROM A DIFFERENT PROVIDER (PLASTIC SURGEON) WHO SWITCHED HER MEDICATION TO BACTRIM DS (BID FOR 7 DAYS) WITH NO IMPROVEMENT IN SYMPTOMS. THE PATIENT REPORTED TO THE TREATING PHYSICIAN THAT ON (B)(6) 2014 THE AREA WAS DRAINED BY THE PLASTIC SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378668 LIPOSONIX SYSTEM LIPOSONIX OHV SOLTA MEDICAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention