BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVANESSE VERSA+

    MDR report key: 9800820 · Received March 6, 2020

    Report

    Report Number
    3004423487-2020-00003
    Event Type
    Malfunction
    Date Received
    March 6, 2020
    Date of Event
    December 11, 2019
    Report Date
    February 4, 2020
    Manufacturer
    ROLLENIUM MEDICAL TECHNOLOGIES INC.
    Product Code
    LMH
    PMA / PMN Number
    P160042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD SUMMARY: THE RETROSPECTIVE REVIEW OF THE BATCH FILE SHOWS THAT NO ELEMENT COULD EXPLAIN THESE ISSUES: THE LOT NUMBER WAS VERIFIED AND HAS BEEN CONFIRMED TO BE RELEASED BY THE COMPANY. THE BATCH RECORD, QC TEST REPORTS, AND TRAINING OF STAFF WERE ANALYZED AND IT HAS BEEN DETERMINED THAT PRODUCT IS WITHIN REQUIRED SPECIFICATIONS , AND MANUFACTURED ACCORDING TO THE APPROPRIATE PROCEDURES. THE BATCH RECORDS AND TEST REPORTS FROM THIS LOT HAS PASSED ALL TESTS AND A CHECK OF THE NCR AND DEVIATION LOG HAS PRODUCED ZERO RESULTS FOR THIS LOT NUMBER. THE CERTIFICATE OF ANALYSIS (C OF A) OF THIS LOT SHOWS THAT ALL TESTING PERFORMED ON THE PRODUCT HAS PASSED. THE MEDICAL DIRECTOR WAS CONTACTED AND HIS RESPONSE WAS SENT TO THE PREMIER PLASTIC SURGERY. THIS ADVERSE EVENT IS UNDER CONSULTATION WITH MEDICAL DIRECTOR.

    Description of Event or Problem · 1

    PATIENT WAS INJECTED ON (B)(6) 2019 WITH 1ML VERSA TO THE LIPS (0.5ML IN TOP AND 0.5 ML IN BOTTOM)USING THE NEEDLE PROVIDED. TOPICAL NUMBING CREAM (LIDO/TETRA) WAS USED. CREAM WAS REMOVED AND SITE WAS CLEANSED WITH HIBICLENS, THEN HYPOCHLOROUS ACID, AND THEN ALCOHOL. SHE IS C/O INTERMITTENT EDEMA IN DIFFERENT AREAS OF THE LIPS. SHE RECENTLY FORMED NODULES AND SENT A PHOTO. SHE REPORTED HAVING A SINUS INFECTION ABOUT A WEEK AFTER THE PROCEDURE. THE PHYSICIAN PRESCRIBED DOXYCYCLINE 100MG BID*2 WEEKS. THIS WAS HER FIRST TIME EVER BEING INJECTED WITH HYALURONIC ACID. BELOW IS MEDICAL OPINION FROM MEDICAL DIRECTOR: "BASED ON THE ONE PHOTO AND LIMITED HISTORY PROVIDED I DO NOT SEE EVIDENCE OF DELAYED INFLAMMATORY NODULES. ALTHOUGH THESE CAN OCCUR AT HA IMPLANT SITES POST INFECTION, THEY USUALLY OCCUR CONTEMPORANEOUSLY WITH THE INFECTION, NOT WEEKS LATER. THE PHOTOGRAPH PROVIDED SHOWS TWO SPOTS OF VERY SUPERFICIAL HYALURONIC ACID CLEARLY VISIBLE THRU THE THIN MUCOSA. ALL GUIDELINES WOULD RECOMMEND DISSOLVING THIS HA WITH HYALURONIDASE, ESPECIALLY AS THE PATIENT HAS EXPRESSED CONCERNS. I WOULD BE PLEASED TO REVIEW THIS CASE AGAIN, ONCE THE ADDITIONAL MEDICAL HISTORY IS AVAILABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260094 REVANESSE VERSA+ REVANESSE VERSA+ LMH ROLLENIUM MEDICAL TECHNOLOGIES INC. 40082 19I085

    Patients

    Seq Age Sex Outcome Treatment
    1 REVANESSE VERSA+