BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 6079175 · Received November 4, 2016

    Report

    Report Number
    3011423170-2016-00001
    Event Type
    Injury
    Date Received
    November 4, 2016
    Date of Event
    September 27, 2016
    Report Date
    October 25, 2016
    Manufacturer
    SOLTA MEDICAL
    Product Code
    OHV
    PMA / PMN Number
    K100874
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS NOT RETURNED FOR EVALUATION. BASED ON ALL INFORMATION, NO CASUAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    THE PATIENT HAD TREATMENT JUST ABOVE THE BILATERAL AND MEDIAL KNEE AREA THREE WEEKS AGO. OVER TIME BRUISING AND SWELLING SPREAD PAINFUL ENOUGH THAT THE PATIENT STATES SHE CANNOT WALK OR WORK THEREFORE WENT TO THE EMERGENCY DEPARTMENT. THE PATIENT WAS GIVEN PERCOCET, WHICH WAS NOT SUFFICIENT FOR PAIN CONTROL, SO SHE HAS RETURNED AND IS NOW GETTING MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729777 SYSTEM, LIPOSONIX, REST OF THE WORLD (ROW), P2.1 LYPOSONIX OTHER OHV SOLTA MEDICAL P006373

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention