BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVANESSE VERSA

    MDR report key: 9378899 · Received November 26, 2019

    Report

    Report Number
    3004423487-2019-00006
    Event Type
    Malfunction
    Date Received
    November 26, 2019
    Report Date
    September 12, 2018
    Manufacturer
    PROLLENIUM MEDICAL TECHNOLOGIES INC
    Product Code
    LMH
    PMA / PMN Number
    P160042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    1 .CORRECTION TO SECTION E1 FROM INITIAL REPORT:- CHANGED THE MDR REPORTER COUNTRY FROM CANADA TO USA.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD SUMMARY: THE RETROSPECTIVE REVIEW OF THE BATCH RECORD SHOWS THAT NO ELEMENT CAUSING THE ISSUE. ALL QUALITY CONTROL HAVE PASSED AND THERE WAS NO LIDOCAINE CONTAIN ADDED. EACH OF THE SYRINGE WERE VISUALLY INSPECTED AFTER FILLING AND NO CONTAMINATION WERE DETECTED.

    Description of Event or Problem · 1

    THE PATIENT GOT HER INJECTION (REVANESSE VERSA - LOT 18G065) ON (B)(6) 2018. INITIALLY THERE WERE BRUISING AND SOME LUMP UNDER HER EYES. AFTER TWO AND A HALF WEEKS LATER THE LUMP WENT DOWN BUT STILL RETAINED SOME PUFFINESS. THE PATIENT WAS CONCERNED ABOUT THOSE IRREGULAR LUMP / PUFFINESS UNDER HER EYES, BECAUSE SHE WAS ABLE TO SEE THE PUFFINESS UNDER HER EYES WITH HER PERIPHERAL VISION WHEN SHE WAS SITTING DOWN. THE PATIENT THINKS THE SITUATION WAS GETTING WORSE, THAT HER VISION WAS BEING AFFECTED TOO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1174841 REVANESSE VERSA REVANESSE VERSA LMH PROLLENIUM MEDICAL TECHNOLOGIES INC 40081 18G065

    Patients

    Seq Age Sex Outcome Treatment
    1