BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVI SYSTEM

    MDR report key: 23215959 · Received October 3, 2025

    Report

    Report Number
    3012239564-2025-00017
    Event Type
    Injury
    Date Received
    October 3, 2025
    Date of Event
    September 3, 2025
    Report Date
    October 3, 2025
    Manufacturer
    BLUEWIND MEDICAL LTD
    Product Code
    QXM
    PMA / PMN Number
    K240037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT STATES THAT HER CT SCAN SHOWED FLUID BUILDUP AND SHE IS SCHEDULED TO SEE IMPLANTING PHYSICIAN DR. (B)(6) ON TUESDAY, (B)(6), FOR AN INCISION AND DRAINAGE. FOR NOW, HOLDING OFF ON USE OF REVI TREATMENTS UNTIL GIVEN CLEARANCE. SHE DID NOT HAVE A COPY OF HER CT SCAN REPORT.

    Description of Event or Problem · 0

    FCS REPORTED THE FOLLOWING: THE PATIENT CAME IN WITH A LUMP ON HER ANKLE WHERE THE IMPLANT IS. NO PAIN. SWELLING. PT STATED IT HAS BEEN THIS WAY SINCE THE IMPLANT ACTIVATION APPT. PT STATED THAT SHE RECEIVED A SECOND ROUND OF ANTIBIOTICS DUE TO POSSIBLE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1744827 REVI SYSTEM IMPLANTED TIBIAL ELECTRICAL URINARY CONTINENCE DEVICE QXM BLUEWIND MEDICAL LTD KA-9000-0001_US_CM

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Other