BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVANESSE VERSA+ 1.2 ML

    MDR report key: 14578466 · Received June 2, 2022

    Report

    Report Number
    3004423487-2022-00024
    Event Type
    Injury
    Date Received
    June 2, 2022
    Date of Event
    April 18, 2022
    Report Date
    June 2, 2022
    Manufacturer
    PROLLENIUM MEDICAL TECHNOLOGIES INC.
    Product Code
    LMH
    UDI-DI
    10669808001038
    PMA / PMN Number
    P160042 S015
    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 CLINICAL COMPLAINTS 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 WILL BE PROVIDED TO THE CLINIC ALONG WITH THE LETTER INDICATING APPROVED AREAS FOR INJECTION FOR REVANESSE VERSA+ PRODUCT WHEN REQUESTED INFORMATION FOR CONDUCTING INVESTIGATION IS PROVIDED.

    Description of Event or Problem · 0

    BASED ON THE INFORMATION PROVIDED, THE PATIENT WAS INJECTED WITH REVANESSE VERSA+ (WITH LIDOCAINE) 1.2 ML IN THE LIPS AREA OF THE PATIENT ON (B)(6) 2022. AMOUNT OF PRODUCT INJECTED WAS 0.6 ML IN THE LIPS AREA OF THE PATIENT, ACCORDING TO THE INITIAL REPORT. PATIENT IS FEMALE; AGE OF THE PATIENT IS 32 YEARS OLD; YEAR OF BIRTH: 1989. ACCORDING TO THE INITIAL REPORT, FOUR WEEKS AFTER THE INJECTION WHEN THE PATIENT WOKE UP IN THE MORNING, HER LIPS WOULD BE SWOLLEN FOR 4-6 HOURS. THE CLINIC RECOMMENDED TAKING BENADRYL AT NIGHT TIME. (B)(6) THE PATIENT REACHED OUT AGAIN TO THE CLINIC AND WAS CONCERNED THAT HER LIPS WERE STILL SWOLLEN. NO INFORMATION REGARDING TOPIC ANAESTHETIC HAS BEEN PROVIDED. NO INFORMATION REGARDING ALLERGIES HAS BEEN PROVIDED. NO INFORMATION REGARDING MEDICAL HISTORY AND PRESENCE OF RISK FACTORS HAVE BEEN PROVIDED. ON (B)(6) 2022, SHORTLY AFTER THE DAY OF NOTIFICATION, THE QA DEPARTMENT AT PROLLENIUM TECHNOLOGIES CONTACTED CLINIC/INJECTOR REQUESTING INFORMATION REGARDING THIS CLINICAL COMPLAINT. ON (B)(6) 2022, QA DEPARTMENT AT PROLLENIUMMEDICAL TECHNOLOGIES CONTACTED CLINIC/INJECTOR AGAIN REQUESTING INFORMATION REGARDING THIS CLINICAL COMPLAINT. NO RESPONSE AS OF 02 JUN 2022 HAS BEEN RECEIVED. THE QA DEPARTMENT WILL CONTINUE THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23713 REVANESSE VERSA+ 1.2 ML REVANESSE VERSA+ LMH PROLLENIUM MEDICAL TECHNOLOGIES INC. 40083 21J109 10669808001038

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female