BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVANESSE VERSA

    MDR report key: 8242078 · Received January 11, 2019

    Report

    Report Number
    3004423487-2009-00003
    Event Type
    Malfunction
    Date Received
    January 11, 2019
    Date of Event
    July 23, 2018
    Report Date
    July 25, 2018
    Manufacturer
    PROLLENIUM MEDICAL TECHNOLOGIES INC.
    Product Code
    LMH
    PMA / PMN Number
    P160042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    [(B)(4)].

    Description of Event or Problem · 1

    PATIENT WAS INJECTED REVANESSE VERSA INTO THE LIPS, WHICH THE NURSE HAD MISSED WITH 0.2CC OF 1% LIDOCAINE. THE PATIENT ALSO RECEIVED A CREAM ON THE LIPS WHICH CONTAINED 23% LIDOCAINE MIXED WITH 7% TETRACAINE POWDER. PATIENT HAD AN ACUTE ANAPHYLACTIC REACTION GETTING INJECTED INTO THE LIPS, THE SYMPTOMS OF THE PATIENT INCLUDE UPPER AIRWAY EDEMA, SHORTNESS OF BREATH, NAUSEA, VOMITING AND TACHYCARDIA. DURING THE TIME IN THE HOSPITAL THE PATIENT HAD RECEIVED EPI PEN0.3MG IM, PEPCID 20MG IM AND SOLU MEDROL 125MG IM IN THE URGENT CARE. LATER ON SHE WS ALSO GIVEN ZYRTEC, PEPCID, PREDNISONE AND AN ALBUTEROL TREATMENT. PATIENT WAS DISCHARGED TO HOME WITH NO FURTHER ISSUES AND BACK TO WORK NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35422 REVANESSE VERSA DERMAL FILLER LMH PROLLENIUM MEDICAL TECHNOLOGIES INC. PN40081 18F032

    Patients

    Seq Age Sex Outcome Treatment
    1