BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVANESSE VERSA

    MDR report key: 8802606 · Received July 18, 2019

    Report

    Report Number
    3004423487-2019-00008
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Date of Event
    November 6, 2018
    Report Date
    November 6, 2018
    Manufacturer
    PROLLENIUM MEDICAL TECHNOLOGIES INC
    Product Code
    LMH
    PMA / PMN Number
    P160042
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE PATIENT RECEIVED 0.85 CC VERSA WITH NO LIDOCAINE IN LIPS ON (B)(6) 2018 AND REPORTED THAT SHE HAD LIP SWELLING ON (B)(6) 2018. LOT # 17K004 EXPIRATION OF DATE JAN 2019. PATIENT HAS HAD PREVIOUS LIP FILLER WITH RESTYLANE REFYNE ON (B)(6) 2017 IN LIPS, 0.5 CC WITH NO PROBLEMS. SHE IS A YOUNG (B)(6) YEAR OLD FEMALE WITH NO MEDICAL ISSUES AND HAS BEEN RECEIVING DYSPORT EVERY 6 MONTHS AND FILLER EVERY YEAR. SWELLING IS ONLY IN UPPER LIPS EVEN THOUGH BOTH UPPER AND BOTTOM LIPS WERE INJECTED. SHE REPORTED RECENTYL, I.E. WITHIN THE LAST 2 WEEKS, THAT HER LIPS STARTED TO SWELL AGAIN AND WAS ADVISED TO TAKE ANTIHISTAMINE OVER THE COUNTER AND THE SWELLING HAS IMPROVED. SHE HAS NOT HAD ANY LIP FILLER SINCE (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599114 REVANESSE VERSA REVANESSE VERSA LMH PROLLENIUM MEDICAL TECHNOLOGIES INC 40081 17K004

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR