BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVANESSE VERSA+ 1.2 ML

    MDR report key: 15863753 · Received November 24, 2022

    Report

    Report Number
    3004423487-2022-00059
    Event Type
    Injury
    Date Received
    November 24, 2022
    Date of Event
    October 19, 2022
    Report Date
    November 24, 2022
    Manufacturer
    PROLLENIUM MEDICAL TECHNOLOGIES
    Product Code
    LMH
    UDI-DI
    10669808001038
    PMA / PMN Number
    P160042 S004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BATCH RECORD, QC TEST REPORTS (07-MAR-2022), AND QC FINAL INSPECTION REVIEW CHECK LIST (21-MAR-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: 22B225 WAS VERIFIED AND HAS BEEN CONFIRMED TO BE RELEASED BY THE COMPANY. PROLLENIUM MEDICAL TECHNOLOGIES INC. HAS CONTACTED (27-OCT-2022;03-NOV-2022;07-NOV-2022; 16-NOV-2022) THE CLINIC TO GET MORE INFORMATION ASSOCIATED WITH THE REPORTED ADVERSE EVENT BUT HAVE GOT NO RESPONSE. THE INCOMPLETE INFORMATION WAS SUBMITTED TO PROLLENIUM MEDICAL TECHNOLOGIES' MEDICAL DIRECTOR. PROLLENIUM HAS SENT A NOTIFICATION LETTER TO THE CLINIC ON 24-NOV-2022 (30 DAY NOTIFICATION) WITH RELATION TO THE LACK OF INFORMATION PROVIDED TO CONTINUE WITH THE INVESTIGATIONS. QA WILL BE CONTINUING TO INVESTIGATE.

    Description of Event or Problem · 0

    BASED ON THE INFORMATION/REPORT PROVIDED BY THE INJECTOR, (B)(6) (MD), THE PATIENT, A 48 YEARS OLD FEMALE, WAS INJECTED WITH 0.52 ML REVANESSE VERSA+ (WITH LIDOCAINE), WHICH WAS DILUTED 50/50 WITH A SALINE, IN NASOJUGAL FOLDS WITH NO DIFFICULTY ON (B)(6) 2022. WITHIN 24 HOURS RIDGES DEVELOPED AT THE INJECTION AREA WHICH ARE GRADUALLY REDUCING. THIS IS NOT A HEMATOMA AND THERE IS NO ERYTHEMA OR OTHER SYMPTOMS. PROLLENIUM MEDICAL TECHNOLOGIES INC. HAS CONTACTED (27-OCT-2022;03-NOV-2022;07-NOV-2022; 16-NOV-2022) THE CLINIC TO GET MORE INFORMATION ASSOCIATED WITH THE REPORTED ADVERSE EVENT BUT HAVE GOT NO RESPONSE. THE INCOMPLETE INFORMATION WAS SUBMITTED TO PROLLENIUM MEDICAL TECHNOLOGIES' MEDICAL DIRECTOR. PROLLENIUM HAS SENT A NOTIFICATION LETTER TO THE CLINIC ON 24-NOV-2022 (30 DAY NOTIFICATION) WITH RELATION TO THE LACK OF INFORMATION PROVIDED TO CONTINUE WITH THE INVESTIGATIONS. QA WILL BE CONTINUING TO INVESTIGATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2707832 REVANESSE VERSA+ 1.2 ML REVANESSE VERSA+ 1.2 ML LMH PROLLENIUM MEDICAL TECHNOLOGIES PN40083 22B225 10669808001038

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Other