BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVANESSE VERSA+ 1.2 ML

    MDR report key: 14859613 · Received June 29, 2022

    Report

    Report Number
    3004423487-2022-00030
    Event Type
    Injury
    Date Received
    June 29, 2022
    Date of Event
    May 25, 2022
    Report Date
    June 29, 2022
    Manufacturer
    PROLLENIUM MEDICAL TECHNOLOGIES INC.
    Product Code
    LMH
    UDI-DI
    10669808001038
    PMA / PMN Number
    P160042 S014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CLINICAL COMPLAINT HAS BEEN INVESTIGATED. THE LOT NUMBER HAS BEEN VERIFIED AND HAS BEEN CONFIRMED TO BE RELEASED BY THE COMPANY. IT HAS BEEN CONFIRMED THAT NO OTHER ADVERSE EVENT WERE FOUND ASSOCIATED WITH THIS LOT NUMBER. THE BATCH RECORD, QC TEST REPORTS, AND TRAINING OF STAFF WERE ANALYSED AND IT HAS BEEN DETERMINED THAT PRODUCT IS WITHIN REQUIRED SPECIFICATIONS, AND MANUFACTURED ACCORDING TO APPROPRIATE PROCEDURES. PROLLENIUM MEDICAL TECHNOLOGIES' MEDICAL DIRECTOR'S RESPONSE TO THIS ADVERSE EVENT TO BE PROVIDED TO THE CLINIC ALONG WITH THE LETTER INDICATING APPROVED AREAS FOR INJECTION FOR REVANESSE VERSA+ PRODUCT: "THE FOLLOWING IS A CLINICAL OPINION BASED ON THE INFORMATION PROVIDED BELOW FROM THE CLINIC. ON (B)(6) 2022 THE PATIENT RECEIVED 1.2 CC OF REVANESSE VERSA + IN THE VERMILLION BORDERS OF THE LIPS AND THE MARIONETTE AREAS. FOUR MONTHS EARLIER ((B)(6) 2021) THE PATIENT HAD THE SAME PROCEDURE PERFORMED HOWEVER THE PRODUCT USED WAS NOT DISCLOSED. ON (B)(6) 2022 THE PATIENT HAD A SEPTOPLASTY PERFORMED ON HER NOSE. SHE WAS PLACED ON ZITHROMYCIN PROPHYLACTICALLY POST PROCEDURE. THIS IS DONE BECAUSE THE NASAL MUCOSA LIKE THE ORAL MUCOSA HAS A HIGH MICROBIAL LOAD WHICH CAN LEAD TO LOCAL INFECTION AND BACTERIA POST SURGICAL DISRUPTION . ON (B)(6), 4 DAYS POST OP THE PATIENT DEVELOPED SWELLING AND ERYTHEMA IN SOME OF HER FILLER TREATMENT AREAS. WHEN SHE WAS SEEN AT THE CLINIC SHE HAD EDEMA AND NODULES AT THE INJECTION SITES IN KEEPING WITH DELAYED INFLAMMATORY NODULES. THESE AREAS WERE TREATED WITH ANTIBIOTICS, MEDROL DOSE PACK AND HYLENEX INJECTIONS. HYLENEX WAS INJECTED ON FOUR MORE VISITS WHICH RESOLVED THE PATIENTS NODULES. MY CLINICAL OPINION IS THAT THIS PATIENT EXPERIENCED DELAYED INFLAMMATORY NODULES DUE TO A BACTERIAL SEEDING FROM THE SURGICAL SEPTOPLASTY. THE ADVERSE EVENT WAS MANAGED CORRECTLY AND THE NODULES RESOLVED. I HOPE THIS CLINICAL OPINION IS OF VALUE TO ALL PARTIES CONCERNED."

    Description of Event or Problem · 0

    BASED ON THE INFORMATION PROVIDED, THE PATIENT WAS INJECTED WITH REVANESSE VERSA+ (WITH LIDOCAINE) 1.2 ML INTO LIPS INTO VERMILION BORDER; MARIONETTE LINES ON INITIAL OBSERVATION AND SUBSEQUENT INJECTIONS LISTED BELOW AREAS OF PATIENT ON (B)(6) 2022. AMOUNT OF PRODUCT INJECTED WAS 1.2 ML, ACCORDING TO THE INITIAL REPORT. PATIENT IS FEMALE, CAUCASIAN; DATE OF BIRTH: (B)(6); AGE OF THE PATIENT: (B)(6). ACCORDING TO THE INITIAL REPORT, THE PATIENT WAS EXPERIENCING EDEMA AND DISCOMFORT TO TREATED AREAS WHEN AWOKE ON (B)(6) 2022. PATIENT STATED SHE DISCONTINUED THE MAGNESIUM SUPPLEMENT ON (B)(6) 2022. THE SYMPTOMS RESOLVED SPONTANEOUSLY WITHIN A FEW DAYS. ON (B)(6) 2022, THE PATIENT HAD SEPTOPLASTY WITHOUT COMPLICATIONS. SHE AWOKE (B)(6) 2022 WITH SWOLLEN, FIRM AREAS TO UPPER AND LOWER LIP AND MARRIONETTE SITES OF INJECTION TREATMENT. HAD S/S BUT DID NOT REPORT TO THE CLINIC UNTIL (B)(6) 2022. PATIENT SEEN ON (B)(6) 2022 WITH MULTIPLE PALPABLE NODULES, EDEMA, TENDERNESS TO TOUCH, ADEQUATE VASCULAR REFILL, MODERATE ERYTHEMA TO TREATMENT SITES, HYLENEX 2.5 ML INJECTED ON (B)(6) 2022 WITH POSITIVE RESPONSE. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY OR DIAGNOSIS. SHE IS SEEN BY PHYSICIAN ANNUALLY FOR GENERAL HEALTH CHECK UP. THE PATIENT TAKES VITAMINS AND A COLLAGEN SUPPLEMENT AT THE TIME OF TREATMENT. SHE HAD ALSO BEEN TAKING A MAGNESIUM SUPPLEMENT OF 150MG (REMAG BRAND) FOR SLEEP, NOT REPORTED AT TIME OF TREATMENT. ON (B)(6) 2022, SHE CHANGED TO A MAGNESIUM PRODUCT CALLED 1ST PHORM WITH A DOSAGE OF 420MG. SHE HAS NOT HAD THE COVID VACCINE NOR A KNOWN CASE OF COVID TO DATE. TREATMENT PLAN: ANTIBIOTIC THERAPY WITH DOXYCYCLINE 100MG PO BID X 10 DAYS, CLINDAMYCIN 300 MG PO TID X 10 DAYS. VALTREX 500 MG PO BID X 7 DAYS AND MEDROL DOSE PACK AS DIRECTED. TREAT AFFECTED AREAS WITH HYLENEX PRN UNTIL PALPABLE NODULES RESOLVE, TISSUE SOFT AND FOLLOW UP DAILY WITH PATIENT. COMMUNICATE WITH MEDICAL DIRECTOR REGARDING THE CASE AND FOLLOW UP PRN. PATIENT HAD JUST COMPLETED A ZPAK ON (B)(6) 2022 FOR HER SEPTOPLASTY SURGERY PERFORMED (B)(6) 2022 PRESCRIBED BY HER SURGEON. (B)(6) 2022 PT WAS STARTED ON DOXYCYCLINE 100 MG PO BID X 10 DAYS, CLINDAMYCIN 300 MG PO TID X 10 DAYS. (B)(6) 2022 STARTED ON VALTREX 500 MG PO BID X 7 DAYS AND MEDROL DOSE PAK. HYLENEX ADMINISTERED (B)(6) 2022 (2.5ML), 6/8/22 (3ML), (B)(6) 2022 (2.5ML), (B)(6) 2022 (1.3ML), 6/15/22 (1.3ML). PATIENT APPLIED COOL COMPRESSES AT HOME. NO OTHER MEDS NOTED. AS REPORTED, THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. ELEVATED FITZPATRICK SCALE OF 2 REPORTED. 5% LIDOCAINE CREAM WAS APPLIED PRIOR TO TREATMENT AND CLEANSED BEFORE TREATMENT DURING THE PROCEDURE. NO ALLERGIES TO DERMAL FILLERS REPORTED. PATIENT IS NOT A FIRST TIME DERMAL FILLER TREATMENT. PATIENT HAD 1ST TREATMENT (B)(6) 2021 AND 2ND TREATMENT (B)(6) 2022. THE MEDICAL DIRECTOR OF THE CLINIC HAS BEEN INFORMED OF THIS ADVERSE EVENT. CURRENT STATUS OF THE PATIENT: PATIENT WAS SEEN THE MORNING OF (B)(6) 2022 WITH PALPABLE SOFT, SLIGHTLY MARGINATED LUMP TO RIGHT AND LEFT UPPER LIP, R ORAL COMMISSURE AND R LOWER MARIONETTE, ALL MEASURING LESS THAN .25CM. AREAS TREATMENT WITH HYLENEX (1.3ML) AND ALL AREAS WERE SOFT TO PALPATION AFTER TREATMENT. MILD EDEMA REMAINS PRESENT TO R ORAL COMMISSURE BUT NO FIRM NODULES OR LUMPS PALPABLE OR NOTED TO ANY OF THE AFFECTED SITES FOLLOWING HYLENEX INJECTIONS ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923690 REVANESSE VERSA+ 1.2 ML REVANESSE VERSA+ LMH PROLLENIUM MEDICAL TECHNOLOGIES INC. 40083 10669808001038

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female