BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVANESSE VERSA+

    MDR report key: 9812411 · Received March 10, 2020

    Report

    Report Number
    3004423487-2020-00004
    Event Type
    Malfunction
    Date Received
    March 10, 2020
    Date of Event
    January 22, 2020
    Report Date
    March 9, 2020
    Manufacturer
    PROLLENIUM MEDICAL TECHNOLOGIES INC.
    Product Code
    LMH
    PMA / PMN Number
    P160042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN ASSISTANT

    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 PHYSICIAN ASSISTANT.

    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. THIS INJECTION WAS CONDUCTED PASS THE EXPIRATION DATE OF THE SYRINGE. THE MEDICAL DIRECTOR WAS CONTACTED. THIS ADVERSE EVENT IS UNDER CONSULTATION WITH MEDICAL DIRECTOR.

    Description of Event or Problem · 1

    PATIENT HAD BEEN TREATED ON (B)(6) 2020 WITH 1.0ML VERSA+ INTO THE LIPS. 3 DAYS AFTER INJECTION SHE HAD ITCHY, BURNING, HOT WELTS AROUND HER MONTH AND CHIN. THE NURSE INJECTOR WOULD DESCRIBE IT AS ALLERGIC DERMATITIS. MEDICATIONS: BEFORE NP THYROID AFTER ANTIBIOTIC AND TOPICAL STEROID. PATIENT WAS GIVEN THE FOLLOWING: COLD COMPRESSES, HYALURONIDASE, ANTI-INFLAMMATORY (IE. ADVIL), PREDNISONE, ZITHROMAX, KEFLEX, OTHER ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278377 REVANESSE VERSA+ REVANESSE VERSA+ LMH PROLLENIUM MEDICAL TECHNOLOGIES INC. 40082 19C043

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR