BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVANESSE VERSA+ 1.2 ML

    MDR report key: 19851822 · Received July 29, 2024

    Report

    Report Number
    3004423487-2024-00015
    Event Type
    Injury
    Date Received
    July 29, 2024
    Date of Event
    May 21, 2024
    Report Date
    July 29, 2024
    Manufacturer
    PROLLENIUM MEDICAL TECHNOLOGIES INC.
    Product Code
    LMH
    PMA / PMN Number
    P160042S004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    117

    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 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.

    Description of Event or Problem · 0

    AS PER THE INJECTOR, NP, A 38 YO PATIENT (PT) WAS INJECTED IN LIPS WITH 0.8 ML OF REVANESSE VERSA+(WITH LIDOCAINE) ON 30-APR-2024. TOPICAL ANESTHETIC (SKNV, LIDO 15% /PHENYLEPHRINE 0.25% / PRILOCAINE 5%) WERE USED. THREE (3) WEEKS LATER, THE PT IS EXPERIENCING NODULES. PATIENT HISTORY SHOWS THAT SHE REPORTEDLY HAD ISSUES WITH INTERMITTENT EDEMA POST TEAR TROUGH FILLER THAT WAS PLACED YEARS AGO BY A DIFFERENT PROVIDER. SHE WAS GIVEN STEROIDS A NUMBER OF TIMES BUT ULTIMATELY REQUIRED DISSOLVING. AT THE TIME SHE AND HER PAST PROVIDERS BELIEVED IT TO BE RELATED TO TEAR TROUGH ANATOMY AND THE DIFFICULTY OF THE TREATMENT AREA / LYMPHATICS. PATIENT REPORTEDLY HAD AN ELEVATED ESR LEVEL IN FEBRUARY 2024 BUT DID NOT CONTINUE ANY INFLAMMATORY WORK UP. SHE WAS ENCOURAGED TO FOLLOW UP WITH PCP TO CONTINUE UNDERGOING BASELINE INFLAMMATORY ISSUE WORK UP. THE BATCH RECORD, QC TEST REPORTS (27-MAY-2022), AND QC FINAL INSPECTION REVIEW CHECK LIST (03-JUN-2022) 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 22E153 WAS VERIFIED AND HAS BEEN CONFIRMED TO BE RELEASED BY THE COMPANY. THE INFORMATION PROVIDED BY THE CLINIC HAS BEEN SUBMITTED TO THE PROLLENIUM MEDICAL DIRECTOR FOR REVIEW. THE PROLLEIUM MEDICAL DIRECTOR'S CLINICAL OPINION IS AS FOLLOWS: "THE FOLLOWING IS A CLINICAL OPINION BASED ON THE INFORMATION PROVIDED IN CASE (B)(4) ON APRIL 30TH, 2024 A PATIENT RECEIVED 0.8 CC OF REVANESSE VERSA+ INTO THEIR LIPS. IN 2018 THEY ALSO HAD VOBELLA INJECTED INTO THEIR LIPS. PRIOR TO INJECTION SKNV TOPICAL ANESTHETIC WAS APPLIED TO THE LIPS. SKNV CONSISTS OF 15% LIDOCAINE, 5% PRILOCAINE & 0.25% PHENYLEPHRINE. THERE WERE NO CONCERNS OR ADVERSE EVENTS AT THE TIME OF INJECTION. THREE WEEKS LATER THE PATIENT SHARED PHOTOS THAT SHOW MILD SWELLING OF THE LIPS THAT SPONTANEOUSLY RESOLVED. THE CLINIC DESCRIBED THIS FINDING AS "NODULES THAT RESOLVE AND REAPPEAR IN DIFFERENT LOCATIONS". THE PATIENT WAS TREATED WITH MEDROL PACK, CLARITHROMYCIN AND IBUPROFEN AND ADVISED THE PATIENT TO FOLLOW UP WITH THEIR PCP " TO CONTINUE ONGOING BASELINE INFLAMMATORY ISSUES WORK UP". MY CLINICAL OPINION BASED ON THE PHOTOS AND INFORMATION PROVIDED IS THAT THIS CASE REPRESENTS MILD INTERMITTENT LIP SWELLING. IF IT IS FELT TO BE RELATED TO THE TWO HA PRODUCTS INJECTED THEN IT SHOULD BE TREATED BY DISSOLVING ALL THE PRODUCTS WITH HYURONIDASE." INTERNAL PROLLENIUM COMPLAINT NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951042 REVANESSE VERSA+ 1.2 ML REVANESSE VERSA+ LMH PROLLENIUM MEDICAL TECHNOLOGIES INC. PN40083 22E153

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female Other