BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIPOSONIX

    MDR report key: 2905512 · Received January 9, 2013

    Report

    Report Number
    2954746-2013-00002
    Event Type
    Injury
    Date Received
    January 9, 2013
    Report Date
    December 10, 2012
    Manufacturer
    SOLTA MEDICAL, INC.
    Product Code
    OHV
    PMA / PMN Number
    K100874
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. SERVICE RECORDS REVIEW SHOWED THERE HAVE BEEN NO SERVICE CALLS FOR THIS SYSTEM. BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE SYSTEM USES HIGH-INTENSITY FOCUSED ULTRASOUND TO DISRUPT SELECTED AREAS OF UNWANTED SUBCUTANEOUS TISSUE AND CONTRACT SUBCUTANEOUS COLLAGEN IN PATIENTS FOR THE PURPOSE OF AESTHETIC BODY SCULPTING. THUS THE TREATMENT HAS A DUAL TISSUE RESPONSE, ADIPOSE TISSUE IS DISRUPTED AND THE COLLAGEN CONTRACT DUE TO THE THERMAL DENATURATION. THE TISSUE DAMAGE STIMULATES MACROPHAGES TO MIGRATE TO THE TREATMENT ZONE; THIS IS A NORMAL INFLAMMATORY RESPONSE TO TISSUE INJURY. LESIONS RESOLVE AS A RESULT OF THE NORMAL HEALING PROCESS IN 8-14 WEEKS RESULTING IN REDUCED TISSUE VOLUME INTERNALLY AND AN AESTHETIC CONTOURING EFFECT EXTERNALLY.

    Description of Event or Problem · 1

    DATE OF THE EVENT - EXACT DATE IS UNKNOWN REPORTED (B)(6) 2012. A PHYSICIAN VOLUNTEERED TO HAVE A DEMONSTRATION OF A NEW SYSTEM PERFORMED UPON HIMSELF, EVEN THOUGH HE WAS A POOR CANDIDATE FOR THE PROCEDURE. THE TREATMENT WAS A FIRST TIME USE OF THE DEVICE AND WAS PERFORMED BY THE PHYSICIAN'S ASSISTANT ON HIS ABDOMEN. PRIOR TO THE TREATMENT, IBUPROFEN WAS TAKEN AND NITROUS OXIDE WAS USED DURING THE TREATMENT. THE PHYSICIAN REPORTED THAT THE PAIN DURING THE TREATMENT WAS TOLERABLE. THE PHYSICIAN REPORTED PROLONGED TISSUE FIRMNESS IN HIS ABDOMEN; AMOUNT OF TISSUE INVOLVEMENT AND EXACT LOCATION IS NOT KNOWN. THE PHYSICIAN IS NOT CURRENTLY RECEIVING ANY TREATMENTS, BUT HAS INDICATED HE MAY SEEK CONSULTATION WITH OTHER PHYSICIANS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11288 LIPOSONIX LIPOSONIX OHV SOLTA MEDICAL, INC. P005700

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other