BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVANESSE LIPS+ 1.2 ML

    MDR report key: 16791911 · Received April 21, 2023

    Report

    Report Number
    3004423487-2023-00007
    Event Type
    Injury
    Date Received
    April 21, 2023
    Date of Event
    March 19, 2023
    Report Date
    March 20, 2023
    Product Code
    LMH
    UDI-DI
    10669808003032
    PMA / PMN Number
    P160042 S014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BASED ON THE INFORMATION/REPORT PROVIDED BY THE SALES REPRESENTATIVE, KELLIE TEEL, RN, INJECTED THE 33-YEAR-OLD FEMALE PATIENT ON (B)(6) 2023 WITH LOT 22K141 OF REVANESSE LIPS+ 1.2 ML - (B)(6). THE FOLLOWING WAS THE CONCERN: "DID THIS GIRLS LIPS LAST NIGHT AND SHE IS CONCERNED THAT FILLER IS OUTSIDE OF THE LIPS. I TOLD HER IT SHOULD NOT BE OUTSIDE OF THE LIPS. LIKELY STILL SWOLLEN. SHE DOES HAVE A NEW CREASE ON THE RIGHT SIDE IF LOOKING AT THE PICTURE." PROLLENIUM MEDICAL TECHNOLOGIES INC. HAS CONTACTED THE CLINIC FOUR TIMES VIA EMAIL AND PHONE (20-MAR-2023, 23-MAR-2023, 03-APR-2023, 18-APR-2023) TO OBTAIN ADDITIONAL INFORMATION ASSOCIATED WITH THE REPORTED ADVERSE EVENT. THE CLINIC DID NOT RESPOND. QA DEPARTMENT AT PROLLENIUM MEDICAL TECHNOLOGIES WILL CONTINUE THE INVESTIGATION. 3004423487-2023-00007, SWELLING (E2338), NOT RELATED TO THE DEVICE (A24) INTERNAL REPORT NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964941 REVANESSE LIPS+ 1.2 ML REVANESSE LIPS+ LMH 40149 22K141 10669808003032

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female