BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIPOSONIX

    MDR report key: 2895562 · Received January 3, 2013

    Report

    Report Number
    2954746-2013-00001
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    June 22, 2012
    Report Date
    December 4, 2012
    Manufacturer
    SOLTA MEDICAL, INC.
    Product Code
    OHV
    PMA / PMN Number
    K100874
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE MANUFACTURER ADVISED THE USER THAT TREATMENT OF THE UPPER ARM IS NOT INDICATED FOR USE IN THE OPERATOR'S MANUAL. SPECIFICALLY INDICATED FOR NON-INVASIVE WAIST CIRCUMFERENCE REDUCTION AND IS LABELED AS CONTRAINDICATED IF ADIPOSE TISSUE THICKNESS IS LESS THAN 1.0 CM BEYOND THE SELECTED FOCAL DEPTH IN THE AREA TO BE TREATED. REVIEW OF THE SERVICE RECORDS INDICATED NO SERVICE HAS BEEN PERFORMED ON THE UNIT BEFORE OR AFTER THIS EVENT. ADDITIONALLY, REVIEW OF THE DOWNLOADED LOG WAS PERFORMED AND NO UNUSUAL ISSUES WERE IDENTIFIED.

    Description of Event or Problem · 1

    REPORTED THAT THE PATIENT RECEIVED TREATMENT TO BOTH ARMS ABOVE THE ELBOW, THIS IS NOT A TREATMENT AREA INDICATED FOR USE IN THE USER MANUAL. THIRTY MINUTES POST TREATMENT THE PATIENT EXPERIENCED TINGLING AND NUMBNESS TO HER FINGERS ON BOTH HANDS. THE FACILITY REPORTED THAT AS OF (B)(6) 2012 THE PATIENT'S FINGERS ARE GETTING STRONGER EXCEPT FOR THE PINKIE AND THE RING FINGER OF BOTH ARMS. THE PATIENT IS REPORTED TO BE UNDER THE CARE OF A PHYSICAL THERAPIST, NERVE DOCTOR AND PSYCHOLOGIST. THE MANUFACTURER HAS BEEN UNABLE TO OBTAIN ANY INFORMATION REGARDING THE NERVE DOCTOR OR CONFIRM IF NERVE DAMAGE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1898 LIPOSONIX LIPOSONIX OHV SOLTA MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other