BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVANESSE LIPS+ - 1.2 ML

    MDR report key: 15601115 · Received October 13, 2022

    Report

    Report Number
    3004423487-2022-00050
    Event Type
    Injury
    Date Received
    October 13, 2022
    Date of Event
    August 8, 2022
    Report Date
    October 12, 2022
    Manufacturer
    PROLLENIUM MEDICAL TECHNOLOGIES
    Product Code
    LMH
    UDI-DI
    10669808003032
    PMA / PMN Number
    P160042 S014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BATCH RECORD, QC TEST REPORTS (22-MAR-2022), AND QC FINAL INSPECTION REVIEW CHECK LIST (04-APR-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 22034 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. PROLLENIUM MEDICAL TECHNOLOGIES INC. HAS CONTACTED ((B)(6) 2022;(B)(6) 2022;(B)(6) 2022; (B)(6) 2022) THE CLINIC TO GET MORE INFORMATION ASSOCIATED WITH THE REPORTED ADVERSE EVENT BUT HAVE GOT NO RESPONSE. PROLLENIUM MEDICAL TECHNOLOGIES' MEDICAL DIRECTOR'S RESPONSE TO THIS ADVERSE EVENT IS AS FOLLOWS: "THE FOLLOWING IS A CLINICAL OPINION BASED ON THE LIMITED INFORMATION PROVIDED IN CASE (B)(6). A PATIENT HAD REVANESSE LIPS INJECTED INTO HER LIPS. NO DATES, QUANTITY, MEDICAL HISTORY, OR PHOTOS WERE PROVIDED. THREE DAYS LATER THE PATIENT CONTACTED THE CLINIC COMPLAINING OF PEELING LIPS. THE CLINIC'S MEDICAL DIRECTOR SAW THE PATIENT AND DIAGNOSED COLD SORES. NO FURTHER HISTORY WAS PROVIDED. MY CLINICAL OPINION IS THAT THIS CASE REPRESENTS A REACTIVATION OF COLD SORE DUE THE TRAUMA OF NEEDLES IN THE LIPS." PROLLENIUM MEDICAL TECHNOLOGIES INC. WILL CONTINUE CONTACTING THE CLINIC TO GET MORE INFORMATION ASSOCIATED WITH THE REPORTED ADVERSE EVENT. A FOLLOW UP REPORT WILL BE SUBMITTED IF MORE INFORMATION WILL BE PROVIDED BY THE CLINIC.

    Description of Event or Problem · 0

    AS THE PER INFORMATION PROVIDED BY THE CLINIC, THE PATIENT WAS INJECTED WITH REVANESSE LIPS+, 1.2ML; LOT # 22C034 ON (B)(6) 2022. THE TREATMENT AREA APPEARED TO BE NORMAL SOON AFTER INJECTION. THE CLINIC'S ASSISTANT PHYSICIAN WHO DID THE INJECTION SAYS FIVE DAYS AFTER TREATMENT, PATIENT CALLED AND COMPLAINED OF BURNING AND SKIN PEELING IN THE TREATMENT AREA. SHE SAID SHE NOTICED THE PEELING AND BURNING 3 DAYS AFTER TREATMENT AND BEGAN USING OTC TOPICAL ANTIBIOTIC CREAM ON HER OWN WITHOUT REPORTING TO THE CLINIC. THE ANTIBIOTIC DID NOT HELP HER SO SHE CAME TO SEE THE INJECTOR. PATIENT WAS ADVISED TO GO TO HER FAMILY PHYSICIAN BECAUSE HE SUSPECTED HERPES OUTBREAK. PHOTOS WERE NOT TAKEN. PATIENT NOW REPORTS THAT SHE FEELS THERE IS NO RESULT (BELIEVES LIPS HAVE RETURNED TO BASELINE). PROLLENIUM MEDICAL TECHNOLOGIES INC. HAS CONTACTED ((B)(6) 2022; (B)(6) 2022; (B)(6) 2022; (B)(6) 2022) THE CLINIC TO GET MORE INFORMATION ASSOCIATED WITH THE REPORTED ADVERSE EVENT BUT HAVE GOT NO RESPONSE. PROLLENIUM MEDICAL TECHNOLOGIES' MEDICAL DIRECTOR'S RESPONSE TO THIS ADVERSE EVENT IS AS FOLLOWS: "THE FOLLOWING IS A CLINICAL OPINION BASED ON THE LIMITED INFORMATION PROVIDED IN CASE (B)(6). A PATIENT HAD REVANESSE LIPS INJECTED INTO HER LIPS. NO DATES, QUANTITY, MEDICAL HISTORY, OR PHOTOS WERE PROVIDED. THREE DAYS LATER THE PATIENT CONTACTED THE CLINIC COMPLAINING OF PEELING LIPS. THE CLINIC'S MEDICAL DIRECTOR SAW THE PATIENT AND DIAGNOSED COLD SORES. NO FURTHER HISTORY WAS PROVIDED. MY CLINICAL OPINION IS THAT THIS CASE REPRESENTS A REACTIVATION OF COLD SORE DUE THE TRAUMA OF NEEDLES IN THE LIPS." PROLLENIUM MEDICAL TECHNOLOGIES INC. WILL CONTINUE CONTACTING THE CLINIC TO GET MORE INFORMATION ASSOCIATED WITH THE REPORTED ADVERSE EVENT. A FOLLOW UP REPORT WILL BE SUBMITTED IF MORE INFORMATION WILL BE PROVIDED BY THE CLINIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2613750 REVANESSE LIPS+ - 1.2 ML REVANESSE LIPS+ - 1.2 ML LMH PROLLENIUM MEDICAL TECHNOLOGIES PN40149 22C034 10669808003032

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other