BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVANESSE

    MDR report key: 14847012 · Received June 28, 2022

    Report

    Report Number
    3004423487-2022-00029
    Event Type
    Injury
    Date Received
    June 28, 2022
    Report Date
    June 28, 2022
    Manufacturer
    PROLLENIUM MEDICAL TECHNOLOGIES INC.
    Product Code
    LMH
    PMA / PMN Number
    P160042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN ASSISTANT
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CLINICAL COMPLAINT IS IN THE PROCESS OF INVESTIGATION. THE LOT NUMBER HAS NOT BEEN VERIFIED DUE TO THE ABSENCE OF INFORMATION. IT WILL BE CONFIRMED WHETHER ANY CLINICAL COMPLAINTS HAVE BEEN FOUND FOR THE PARTICULAR LOT NUMBER IN QUESTION ONCE REQUESTED INFORMATION IS PROVIDED. THE BATCH RECORD, QC TEST REPORTS, AND TRAINING OF STAFF WILL BE ANALYSED AND BE DETERMINED THAT PRODUCT IS WITHIN REQUIRED SPECIFICATIONS, AND MANUFACTURED ACCORDING TO APPROPRIATE PROCEDURES ONCE LOT IS VERIFIED. 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+ AND REVANESSE LIPS+ PRODUCTS WHEN REQUESTED INFORMATION FOR CONDUCTING INVESTIGATION IS PROVIDED.

    Description of Event or Problem · 0

    BASED ON THE INFORMATION PROVIDED, THE PATIENT GOT INJECTED WITH 1.2 ML OF REVANESSE DERMAL FILLERS IN THE LIPS AREA OF THE PATIENT ON AN UNSPECIFIED DATE. THE LOT OF THE PRODUCT INJECTED WAS NOT PROVIDED AND, THEREFORE, NOT VERIFIED. ACCORDING TO THE INITIAL COMMUNICATION, AFTER SEEING AN INITIAL RESULT, IN A FEW WEEKS NO RESULT WAS VISIBLE. DATE OF BIRTH NOT PROVIDED. 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. SINCE THE DAY OF NOTIFICATION, THE QA DEPARTMENT HAS ATTEMPTED TO CONTACT THE INJECTOR AND CLINIC AGAIN TO INQUIRE ADDITIONAL INFORMATION REGARDING THE EVENT, HOWEVER NO RESPONSE HAS BEEN RECEIVED. AS OF (B)(6) 2022, NO RESPONSE FROM THE CLINIC HAS BEEN RECEIVED. THE QA DEPARTMENT AT PROLLENIUM MEDICAL TECHNOLOGIES WILL CONTINUE THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734650 REVANESSE REVANESSE LMH PROLLENIUM MEDICAL TECHNOLOGIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female