BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHA2

    MDR report key: 14676252 · Received June 10, 2022

    Report

    Report Number
    MW5110259
    Event Type
    Injury
    Date Received
    June 10, 2022
    Date of Event
    May 11, 2022
    Report Date
    June 9, 2022
    Manufacturer
    TEOXANE S.A.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SZ
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WENT INTO PLASTIC SURGERY SPECIALISTS OFFICE IN (B)(6) FOR LIP INJECTIONS. HAD IT DONE BEFORE USING JUVEDERM ULTRA, NEVER HAD A PROBLEM. INJECTOR OFFERED TO USE A NEW PRODUCT AND NEW TECHNIQUE SHE HAD LEARN. THE PRODUCT WAS RHA2 BY REVANCE. NEVER HEARD OF IT BUT I TRUSTED THE INJECTOR. WOKE UP IN THE MIDDLE OF THE NIGHT LOOKING LIKE A FREAK, IN PAIN, LIPS SWOLLEN SO MUCH ALL I HAD IN HAND WAS A COLD CLOTH TO EASE THE FEELING THAT MY LIPS WERE ABOUT TO BURST OPEN. FORTUNATELY MY FRIEND HAD PREDNISONE AND OVER THE NEXT 2 DAYS MY LIPS FINALLY WENT DOWN. UNFORTUNATELY THIS PROCESS CAUSED SOME ISSUES. MY LIPS LOOK AND FEEL LIKE A MINE FIELD. I HAVE LUMPS EVERYWHERE. IT'S HORRIBLE, UNEVEN AND LOOKS BAD. SINCE I AM NOW BACK IN (B)(6) I CAN'T GO BACK TO HAVE THE PRODUCT REMOVE AND REPLACED BY ANOTHER ONE. I DON'T BELIEVE THAT THIS SPECIFIC PRODUCT WAS EVEN MADE FOR LIPS INJECTIONS. QUANTITY: 1 INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1687686 RHA2 IMPLANT, DERMAL, FOR AESTHETIC USE LMH TEOXANE S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female