BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVANESSE VERSA

    MDR report key: 8785462 · Received July 12, 2019

    Report

    Report Number
    3004423487-2019-00005
    Event Type
    Malfunction
    Date Received
    July 12, 2019
    Date of Event
    June 19, 2018
    Report Date
    August 15, 2018
    Manufacturer
    PROLLENIUM MEDICAL TECHNOLOGIES INC.
    Product Code
    LMH
    PMA / PMN Number
    P160042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    1.CORRECTION TO SECTION E1 FROM INITIAL REPORT:- CHANGED THE MDR REPORTER COUNTRY FROM CANADA TO USA. 2. CORRECTION TO SECTION E2 FROM INITIAL REPORT:- CHANGED HEALTH PROFESSIONAL TO YES. 3. CORRECTION TO SECTION E3 FROM INITIAL REPORT:-CHANGED OCCUPATION TO NURSE PRACTITIONER.

    Description of Event or Problem · 1

    PATIENT - (REFERRED AS EMPLOYEE 2 JP) : (B)(6) 2018; RECEIVED 1ML SYRINGE OF VERSA MIXED WITH 0.3ML OF 1% LIDOCAINE IN LIPS. NURSE USED 27G 1.5IN CANNULA WITH A RETROGRADE INJECTION TECHNIQUE. WITHIN 24HRS POST INJECTION JP NOTICED SIGNIFICANT INCREASE IN TISSUE SWELLING AND THE PRODUCT LOOKED LIKE IT HAS BECOME HARD LUMPS. ADVISED TO WAIT 2 WEEKS FOR SIDE EFFECTS TO SUBSIDE. (B)(6) 2018; SEVERAL AREAS REMAIN SIGNIFICANTLY SWOLLEN AND APPEAR LUMPY OR AS IF THE PRODUCT HAD BALLED UP. ATTEMPTED TO MANIPULATE PRODUCT TO SEE IF PALPATING WOULD SOFTEN THE AREAS BUT WAS UNABLE TO MANIPULATE. BOTTOM L LIP; INJECTED WITH 0.2 ML HYALURONIDASE DIRECTLY INTO THAT AREA. ALSO INJECTED 0.2ML HYALURONIDASE INTO L UPPER LIP. INJECTED 0.1ML INTO R UPPER LIP. (B)(6) 2018; SWELLING IN AREAS TREATED WITH HYALURONIDASE HAD DECREASED, HOWEVER, R LOWER LIP STILL WITH SIGNIFICANT SWELLING. INJECTED 0.2ML HYALURONIDASE IN R LOWER LIP. INJECTED 0.15ML INTO L LOWER LIP AND 0.1ML INTO R UPPER LIP. INJECTED L UPPER LIP WITH 0.05ML. (B)(6) 2018; JP STILL HAS NOTICEABLE BUMP IN R LOWER LIP AND SMALL RAISED RIDGE TO L LOWER LIP AFTER 2 INJECTIONS WITH HYALURONIDASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580991 REVANESSE VERSA DERMAL FILLER LMH PROLLENIUM MEDICAL TECHNOLOGIES INC. PN40081 17K004

    Patients

    Seq Age Sex Outcome Treatment
    1