BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVANESSE LIPS+ - 1.2 ML

    MDR report key: 15584153 · Received October 11, 2022

    Report

    Report Number
    3004423487-2022-00048
    Event Type
    Injury
    Date Received
    October 11, 2022
    Date of Event
    September 30, 2022
    Report Date
    October 11, 2022
    Manufacturer
    PROLLENIUM MEDICAL TECHNOLOGIES INC.
    Product Code
    LMH
    UDI-DI
    01066980800302
    PMA / PMN Number
    P160042 S014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE BATCH RECORD, QC TEST REPORTS AND QC FINAL INSPECTION REVIEW CHECK LIST WERE ANALYSED 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 22G091 WAS VERIFIED AND HAS BEEN CONFIRMED TO BE RELEASED BY THE COMPANY. THE BATCH RECORD, QC TEST REPORTS, AND TRAINING OF STAFF WERE ANALYSED 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. NO OTHER CLINICAL COMPLAINT WAS FOUND ASSOCIATED WITH THIS LOT NUMBER.

    Description of Event or Problem · 0

    PATIENT INFORMATION: THE PATIENT, FEMALE IS A 33-YEAR-OLD (DOB (B)(6) 1987). MEDICAL HISTORY IS AS FOLLOWS, PATIENT HAS HAD A BREAST AUGMENTATION SURGERY IN 2019. ADVERSE EVENT INFORMATION: BASED ON THE INFORMATION PROVIDED, THE PATIENT WAS INJECTED ON (B)(6) 2022 WITH REVANESSE LIPS+ (WITH LIDOCAINE); LOT 22G091 WITH AN INJECTION VOLUME OF 1ML OF PRODUCT INTO THE LIPS. INJECTOR WAS (B)(6), REGISTERED NURSE (RN) FOR THE CLINIC. TOPICAL ANAESTHETIC BLT WAS USED. NO MEDICATIONS BEFORE TREATMENT. ON (B)(6) 2022, 3AM PATIENT REACHED OUT TO CLINIC REPORTING EXTREME SWELLING. PATIENT WENT TO THE HOSPITAL AND WAS GIVEN BENADRYL, TWO STEROID PILLS OF FAMOTIDINE, AND THEN PRESCRIBED PREDNISONE 20MG. PROLLENIUM MEDICAL TECHNOLOGIES INC. HAS CONSULTED ITS MEDICAL DIRECTOR AND HIS RESPONSE TO THE INCIDENT IS DETAILED BELOW. "THE FOLLOWING IS A CLINICAL OPINION BASED ON THE INFORMATION PROVIDED IN (B)(4). ON (B)(6) 2022, A PATIENT RECEIVED REVANESSE LIPS+ INJECTED INTO HER UPPER AND LOWER LIPS. PRIOR TO INJECTION HIGH DOSE BETACAINE, LIDOCAINE AND TETRACAINE WAS APPLIED TO THE PATIENT'S LIPS IN A TRANSDERMAL CARRIER. LATER THAT NIGHT THE PATIENT WENT TO THE ER WITH ANGIOEDEMA OF THE LIPS. SHE WAS TREATED WITH BENADRYL, FAMOTIDINE AND PREDNISONE. HER SYMPTOMS RESOLVED. THE FILLER WAS NOT DISSOLVED. BASED ON THE TWO TREATMENT VARIABLES THAT COULD CAUSE ANGIOEDEMA MY CLINICAL OPINION IS THAT THIS REACTION WAS FROM THE HIGH DOSE TOPICAL ANESTHETICS, IN A TRANSDERMAL ABSORBING BASE, APPLIED TO THE THIN EPITHELIUM OF THE LIPS. THE HA FILLER WAS NOT DISSOLVED AND THE PATIENTS SWELLING RESOLVED AND DID NOT RETURN. IT IS THEREFORE UNLIKELY THAT HA WAS THE CAUSE OF HER ANGIOEDEMA. MY CLINICAL OPINION IS THAT THE REACTION WAS FROM THE PROCEDURE NOT THE HA PRODUCT." THIS INFORMATION FROM THE MEDICAL DIRECTOR WAS COMMUNICATED TO THE TREATING PHYSICIAN. FOLLOW UP COMMUNICATIONS WITH CLINIC: WHEN MANUFACTURER REACHED OUT FOR FURTHER INFORMATION ON PATIENT STATUS, CLINIC REPORTED THAT SWELLING IS SLOWLY DECREASING, NO CHANGE IN COLOUR, NO PAIN OR TROUBLE BREATHING WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2351012 REVANESSE LIPS+ - 1.2 ML REVANESSE LIPS+ - 1.2 ML LMH PROLLENIUM MEDICAL TECHNOLOGIES INC. PN40149 22G091 01066980800302

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Other