BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRASHAPE

    MDR report key: 4858582 · Received June 18, 2015

    Report

    Report Number
    3004772125-2015-00002
    Event Type
    Injury
    Date Received
    June 18, 2015
    Date of Event
    May 22, 2015
    Report Date
    June 17, 2015
    Manufacturer
    SYNERON MEDICAL LTD.
    Product Code
    OHV
    PMA / PMN Number
    K141708
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS FOUND THAT ULTRASHAPE SYSTEM WAS WITHIN SPECIFICATIONS ACCORDING TO UPON ARRIVAL TESTING. SERVICE WAS ABLE TO PERFORM A USER SET UP FOR A TREATMENT WITH NO PROBLEMS. UPON REVIEWING ALL AVAILABLE INFORMATION, THE MOST PROBABLY ROOT CAUSE IS UNKNOWN AT THIS TIME. CURRENTLY, NO FAULTS WERE FOUND WITH ULTRASHAPE SYSTEM OR TREATMENT PROTOCOL. FURTHER INVESTIGATION WILL BE CONDUCTED TO DETERMINE THE TECHNICAL STATUS OF THE TRANSDUCER.

    Description of Event or Problem · 1

    ON (B)(6), 2015, (B)(6), WAS MADE AWARE OF A POSSIBLE ADVERSE EVENT THAT OCCURRED TO A PATIENT OF APPEARANCE CARE CENTER. PATIENT REPORTEDLY SUSTAINED BURNS POST TREATMENT WITH ULTRASHAPE TREATMENT. PATIENT (B)(6), IS A (B)(6) FEMALE, CAUCASIAN PATIENT. IT WAS PATIENT'S SECOND SESSION DURING WHICH SHE WAS TREATED ON THE LOWER ABDOMEN FOR CIRCUMFERENCE REDUCTION. PATIENT HAD 19.1 BMI AND FAT THICKNESS MEASURING 3 INCHES ON THE TREATED AREA. VDF TRANSDUCER WAS USED, STRAPPING WAS DONE AND PARKER'S ULTRASONIC GEL WAS ADMINISTERED DURING TREATMENT. TREATMENT PROVIDER STATED THE PATIENT DID NOT EXPRESS ANY UNUSUAL COMPLAINTS DURING THE TREATMENT. POST TREATMENT, THE PATIENT WAS GIVEN NITROMED, ANTIBIOTIC OINTMENT, WARM COMPRESS AS PART OF ONGOING INJURY CARE. 3CM2 AREA APPEARS COMPLETE DERMALPLEXES COMPROMISED. SURROUND AREA OF 4X15 CM APPEARED AS ERYTHEMA AND EPIDERMOLYSIS. PHOTOS FROM THE DAY OF THE TREATMENT SHOW INJURY MODERATE IN SEVERITY. PHOTO OF THE TRANSDUCER MEMBRANE SHOWS COMPROMISED SURFACE (UNSMOOTH).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396010 ULTRASHAPE NONE OHV SYNERON MEDICAL LTD. FG71051US

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other