BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM, LIPOSONIX, REST OF THE WORLD (ROW) P2.1

    MDR report key: 4924213 · Received July 16, 2015

    Report

    Report Number
    3004106598-2015-00003
    Event Type
    Injury
    Date Received
    July 16, 2015
    Date of Event
    May 23, 2015
    Report Date
    June 26, 2015
    Manufacturer
    SOLTA MEDICAL
    Product Code
    OHV
    PMA / PMN Number
    K100874
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION OF THE SYSTEM LOGS AND ANY APPLICABLE ACCESSORIES HAS BEEN COMPLETED. ALL SYSTEM DATA INDICATED THAT THE SYSTEM WAS WORKING WITHIN SPECIFICATION. NO FAILURE WAS DETECTED. BASED ON ALL INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

    Additional Manufacturer Narrative · 1

    THE UNIT WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM ANY DEVICE FAILURE.

    Description of Event or Problem · 1

    AN ADVERSE EVENT REPORT WAS RECEIVED FROM A USER FACILITY IN (B)(6) INDICATING THAT THE PATIENT RECEIVED THERMAL BURNS FROM A LIPOSONIX TREATMENT IN THE ABDOMEN. THE TREATING PHYSICIAN ALLEGES THAT CRUSTS OCCURRED, WHICH PEELED OFF AND HEALED. HOWEVER, AS A RESULT, THE PATIENT SUFFERED POST-INFLAMMATORY HYPER- PIGMENTATION. PIH WILL RESOLVE OVER TIME WITH TREATMENT. THE PHYSICIAN STATED THAT THERE WERE NO DEVICE ERROR MESSAGES NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463825 SYSTEM, LIPOSONIX, REST OF THE WORLD (ROW) P2.1 LIPOSONIX OTHER OHV SOLTA MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other