BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIPOSONIX SYSTEM

    MDR report key: 3010358 · Received March 19, 2013

    Report

    Report Number
    2954746-2013-00005
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 21, 2013
    Manufacturer
    SOLTA MEDICAL, INC.
    Product Code
    OHV
    PMA / PMN Number
    K112626
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT PROTOCOL GUIDE STATES: TO AVOID INJURY, THE HEALTH CARE PROFESSIONAL SHOULD ASSESS THE PATIENT AND AREA TO BE TREATED AND EVALUATE THE PATIENT FOR THE FOLLOWING CONDITIONS: [...]. A PATIENT WHO HAS SKIN FOLDS IS AN INAPPROPRIATE CANDIDATE. IN ADDITION, AIR MAY BE TRAPPED WITHIN SKIN FOLDS. EVALUATION OF THE TREATMENT TIP AND THE SYSTEM DATA IS PENDING.

    Description of Event or Problem · 1

    A PATIENT TREATED WITH HIGH INTENSITY FOCUSED ULTRASOUND ON HER ABDOMEN, FOR WAIST CIRCUMFERENCE REDUCTION, DEVELOPED A TENDER LUMP IN HER MID-ABDOMEN A FEW DAYS POST TREATMENT. AN ULTRASOUND SHOWED "NO COLLECTION." THE PHYSICIAN REPORTED THAT THE PATIENT EXPERIENCED MILD PAIN DURING THE PROCEDURE (PATIENT WAS NOT PRE-MEDICATED) AND HAD DEVELOPED BRUISING POST TREATMENT. ON (B)(6) 2013, THE PHYSICIAN REPORTED A PALPABLE MASS (7 X 7 CM) VERY HARD, RED AND TENDER TO THE TOUCH IN THE TREATMENT AREA. AN ULTRA-SOUND OF THE PATIENT'S ABDOMEN SHOWED A MASS (2.8 X 1.7CM) BELOW THE UMBILICUS. THERE WAS NO VASCULARIZATION IN THE MASS AND IT SEEMED TO BE ONLY SOLID. ON (B)(6) 2013, THE PATIENT WAS STARTED ON ORAL ANTIBIOTICS TO PREVENT INFECTION. ON (B)(6) 2013, THE PATIENT CONSULTED WITH A GENERAL SURGEON, 4 DAYS LATER THE SURGEON ADMITTED THE PATIENT TO A PRIVATE HOSPITAL, NO SURGERY WAS PERFORMED, HOWEVER "OOZING" WAS OBSERVED FROM THE ABDOMEN. THE PATIENT WAS PUT ON IV ANTIBIOTICS FOR 3 DAYS AND DRESSINGS WERE APPLIED TO THE ABDOMEN. NO FURTHER ADDITIONAL INFORMATION HAS BEEN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113549 LIPOSONIX SYSTEM FOCUSED ULTRASOUND FOR TISSUE AND HEAT OR MECHANICAL OR CELLULAR DISRUPTION OHV SOLTA MEDICAL, INC. P005999 000G5R

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R