BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVANESSE VERSA

    MDR report key: 8802607 · Received July 18, 2019

    Report

    Report Number
    3004423487-2019-00009
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Report Date
    March 12, 2019
    Manufacturer
    PROLLENIUM MEDICAL TECHNOLOGIES INC
    Product Code
    LMH
    PMA / PMN Number
    P160042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE BATCH RECORD AND TEST REPORT FOR LOT 17K090 WERE CHECKED AND VERIFIED. THE CERTIFICATE OF ANALYSIS, MANUFACTURING BATCH RECORD CHECKLIST, QUALITY CONTROL TEST REPORT AND PACKAGING DOCUMENTS WERE CHECKED AND DID NOT FIND ANY IRREGULARITIES IN THE RECORDS. ALL THE RECORDS WERE IN COMPLIANCE WITH STANDARD SPECIFICATIONS AND PRODUCT HAS PASSED. THERE IS NO DEVIATION OR NCR WAS ASSOCIATED WITH THIS LOT NUMBER.

    Description of Event or Problem · 1

    THE PATIENT WAS INJECTED WITH REVANESSE VERSA (17K090) BY DR. (B)(6) ON (B)(6) 2019 INTO THE LIPS. THE PATIENT RECEIVED A TOPICAL APPLICATION OF LIDOCAINE 23% AND TETRACAINE 7% MIXED AT NOLA DISCOUNT. AFTER 12 HOURS, THE PATIENT REPORTED HAVING HIVES AND SWOLLEN LIPS. DR. TREECE TREATED PATIENT WITH A MEDROL (METHYLPREDNISOLONE) DOSE. ON (B)(6) 2019, THE PATIENT REPORTED THAT THE LIP AREA WAS IMPROVING. THE PATIENT HAD BEEN TREATED IN THE PAST YEAR WITH A REVANESSE VERSA INJECTION WITHOUT DEVELOPING ANY ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599099 REVANESSE VERSA REVANESSE VERSA LMH PROLLENIUM MEDICAL TECHNOLOGIES INC

    Patients

    Seq Age Sex Outcome Treatment
    1