BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVANESSE VERSA+

    MDR report key: 16035420 · Received December 22, 2022

    Report

    Report Number
    3004423487-2022-00063
    Event Type
    Injury
    Date Received
    December 22, 2022
    Date of Event
    November 22, 2022
    Report Date
    December 22, 2022
    Manufacturer
    PROLLENUIM MEDICAL TECHNOLOGIES INC.
    Product Code
    LMH
    UDI-DI
    10669808001038
    PMA / PMN Number
    P160042 S004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BATCH RECORD, QC TEST REPORTS AND QC FINAL INSPECTION REVIEW CHECK LIST WERE ANALYZED AND IT HAS BEEN DETERMINED THAT THE PRODUCT WAS RELEASED WITHIN FINAL RELEASE SPECIFICATIONS. THE RETROSPECTIVE REVIEW OF THE BATCH FILE SHOWS THAT NO ELEMENT COULD EXPLAIN THESE ISSUES. THE LOT NUMBER 22E082 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 HAD BEEN DETERMINED THAT PRODUCT IS WITHIN REQUIRED SPECIFICATIONS, AND MANUFACTURED ACCORDING TO THE APPROPRIATE PROCEDURES. THE BATCH RECORDS AND REST OF THE REPORTS FOR THIS LOT HAD PASSED ALL TESTS AND A CHECK OF THE NCR LOG FOR THIS LOT NUMBER HAS PRODUCED ZERO RESULTS FOR THIS LOT NUMBER. THE CHECK ON THE DEVIATION LOG HAD PRODUCED ZERO RESULTS FOR THIS LOT NUMBER AS WELL. THE CERTIFICATE OF ANALYSIS (COA) OF THIS LOT SHOWS THAT ALL TESTING PERFORMED ON THE PRODUCT HAS PASSED. ALL EMPLOYEES ASSOCIATED WITH THE MANUFACTURING, QC TESTING AND PACKAGING HAVE BEEN TRAINED ON THE PROCEDURES AND DOCUMENTS ASSOCIATED WITH ALL THE REVANESSE VERSA+ 1.2 ML PRODUCTS.

    Description of Event or Problem · 0

    BASED ON THE INFORMATION/REPORT PROVIDED BY CLINIC PATIENT, A 72-YEAR-OLD FEMALE, WAS INJECTED WITH REVANESSE VERSA+ IN MID-FACE AREA TO CORRECT A FACIAL DEPRESSION. PRODUCT WOULD NOT MOLD WITHIN THE TISSUE AND WOULD NOT DISPERSE WITH MASSAGING; LOCALIZED BUMP. TOPICAL ANESTHETIC GELS WERE USED PRIOR TO INJECTION; LIDOCAINE 23% AND TETRACAINE 7%. PATIENT WAS INJECTED 0.3 ML OF REVANESSE VERSA+ TO MID-FACE AREA TO CORRECT A FACIAL DEPRESSION. PATIENT HAS RECEIVED TWO (2) TREATMENTS OF HYALURONIDASE TO DISSOLVE THE "BUMP." AS PART OF THE INVESTIGATIONS, PROLLENIUM'S MEDICAL TECHNOLOGIES INC. HAD REQUESTED ITS OWN MEDICAL DIRECTOR'S OPINION AND HIS REVIEW IS DETAILED BELOW: "THE FOLLOWING IS A CLINICAL OPINION BASED ON THE INFORMATION PROVIDED IN CASE (B)(4). ON (B)(6) 2022, A 72 YO PATIENT RECEIVED INJECTIONS OF REVANESSE VERSA + INTO AREAS OF THEIR FACE. COMPOUNDED TOPICAL ANESTHETIC (LIDOCAINE 23% + TETRACAINE 7%) WAS APPLIES BEFORE INJECTION. THE PATIENT HAS A PAST HISTORY OF SILICONE-BASED IMPLANTS IN THEIR CHIN AND ZYGOMATIC ARCHES. THE EXACT LOCATION OF INJECTIONS WAS NOT PROVIDED. A SMALL AMOUNT OF PRODUCT (0.3 CC) WAS INJECTED INTO THE " MID-FACE AREA " TO CORRECT A " DEPRESSION." AT SOME LATER DATE A "BUMP THAT WOULD NOT EVEN UP WITH MASSAGE" IN THE SAME AREA WAS DISSOLVED WITH HYALURONIDASE. THERE IS NO HISTORY OF NODULES, PAIN, ERYTHEMA, SWELLING OR INFLAMMATION. NO OTHER AREAS OF VERSA HA INJECTIONS WERE INVOLVED. MY CLINICAL OPINION, BASED ON THE INFORMATION PROVIDED SUGGESTS THAT THIS CASE REPRESENTS AN APPROPRIATE CORRECTION OF A SUBOPTIMAL PRODUCT PLACEMENT. I SEE NO EVIDENCE OF A PRODUCT AE. I HOPE THIS CLINICAL OPINION IS OF VALUE TO ALL PARTIES CONCERNED." INTERNAL REPORT NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2840309 REVANESSE VERSA+ REVANESSE VERSA+ 1.2 ML LMH PROLLENUIM MEDICAL TECHNOLOGIES INC. 40083 22E082 10669808001038

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female