BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVANESSE VERSA+ 1.2 ML

    MDR report key: 20727243 · Received November 19, 2024

    Report

    Report Number
    3004423487-2024-00025
    Event Type
    Injury
    Date Received
    November 19, 2024
    Date of Event
    October 16, 2024
    Report Date
    November 19, 2024
    Manufacturer
    PROLLENIUM MEDICAL TECHNOLOGIES, AURORA, ON
    Product Code
    LMH
    UDI-DI
    10669808001038
    PMA / PMN Number
    P160042 S004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    117

    Narratives

    Description of Event or Problem · 0

    THE TREATING NP'S ACCOUNT: "SLIGHT DISCOLORATION NOTED AT INJECTION AREA OF PYRIFORM FOSSA AND NOSE. PT DISSOLVED DAY OF INJECTION. FURTHER DISSOLVED NEXT 2 DAYS. MEDS PRESCRIBED: MEDROL, CLINDAMYCIN, KEFLEX, ASA, VIAGRA, NITROPASTE AND WARM COMPRESSES USED. AS OF (B)(6) CLIENT REPORTS IT HAS RESOLVED. UNSURE IF THIS WAS A VASCULAR COMPRESSION VS OCCLUSION. NO SPECIFIC SITE FOUND IMPAIRING BLOOD FLOW ON 2 DIFFERENT ULTRASOUNDS." PROLLENIUM MEDICAL TECHNOLOGIES INC.: "THE FOLLOWING IS A CLINICAL OPINION BASED ON THE INFORMATION PROVIDED IN CASE (B)(4). ON (B)(6) 2024 A PATIENT HAD REVANESSE VERSA+ INJECTED INTO THEIR NOSE AND PYRIFORM FOSSA. COMPOUNDED BLT TOPICAL ANESTHETIC WAS APPLIED PRIOR TO INJECTION. THE NP INJECTOR NOTICED "DISCOLOURATION" IN THE AREA OF INJECTION, SO THE AREA WAS TREATED AS A VASCULAR COMPROMISE AND THE PRODUCT WAS "DISSOLVED". THE DISCOLOURATION RESOLVED. NO OTHER HISTORY OR PHOTOS WERE PROVIDED. MY CLINICAL OPINION IS THAT THIS CASE REPRESENTS A CASE OF VASCULAR OCCLUSION WHICH WAS TREATED SUCCESSFULLY BY DISSOLVING THE PRODUCT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2009338 REVANESSE VERSA+ 1.2 ML REVANESSE VERSA+ 1.2 ML LMH PROLLENIUM MEDICAL TECHNOLOGIES, AURORA, ON PN40083 24D136 10669808001038

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Other