BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVANESSE VERSA+

    MDR report key: 9708648 · Received February 13, 2020

    Report

    Report Number
    3004423487-2020-00002
    Event Type
    Malfunction
    Date Received
    February 13, 2020
    Date of Event
    January 8, 2020
    Report Date
    February 10, 2020
    Manufacturer
    ROLLENIUM MEDICAL TECHNOLOGY INC.
    Product Code
    LMH
    PMA / PMN Number
    P160042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    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; PROVINCE CHANGED TO (B)(6). 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 HAS PRODUCED ZERO RESULTS FOR THIS LOT NUMBER. THE CHECK ON THE DEVIATION LOG HAS PRODUCED ONE PLANNED DEVIATION OF FILLING AND STOPPERING VERSA PRODUCT USING THE FSV-FSR COLANAR ((B)(4)) MACHINE DUE TO PERFORMANCE ISSUES WITH THE BD HYPAK STOPPERING MACHINE. THE CERTIFICATE OF ANALYSIS (C OF A) OF THIS LOT SHOWS THAT ALL TESTING PERFORMED ON THE PRODUCT HAS PASSED. RAJEUNIR MEDICAL SPA WAS CONTACTED AND THIS ADVERSE EVENT IS UNDER CONSULTATION WITH MEDICAL DIRECTOR. [(B)(4)].

    Description of Event or Problem · 1

    TOPICAL LIDOCAINE WAS APPLIED TO LIPS. AREA WAS CLEANSED WITH HIBICLENS. 0.8ML VERSA WAS INJECTED INTO THE LIPS. PATIENT HAS SOME SWELLING POST INJECTION, BUT NOT CONCERNING AT THAT TIME. SHE STATES SWELLING STARTED APPROXIMATELY 3 HOURS LATER WHERE SHE PRESENTED TO THE ER WHERE SHE WAS GIVEN BENEDRYL AND SOLUMEDROL. INITIAL INJECTION DATE WAS (B)(6) 2020. ON (B)(6) 2020 PATIENT SENT NEW PICTURES, STATING SWELLING IS BETTER BUT STILL PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172940 REVANESSE VERSA+ REVANESSE VERSA+ LMH ROLLENIUM MEDICAL TECHNOLOGY INC. 40082 19J056

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR