BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVI SYSTEM

    MDR report key: 22790179 · Received August 12, 2025

    Report

    Report Number
    3012239564-2025-00009
    Event Type
    Injury
    Date Received
    August 12, 2025
    Date of Event
    July 14, 2025
    Report Date
    August 12, 2025
    Manufacturer
    BLUEWIND MEDICAL LTD
    Product Code
    QXM
    UDI-DI
    07290017912226
    PMA / PMN Number
    K240037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PHYSICIAN DID AN ULTRASOUND ON THE PATIENT'S ANKLE. THE PHYSICIAN REPORTS IT WAS NORMAL. PHYSICIAN ORDERED A CYSTO TO SEE IF THERE ARE ANY OTHER ISSUES AFFECTING THE PATIENT'S UUI (PATIENT REPORTS NOCTURIA 1-2X PER NIGHT AND UUI FREQUENCY OF 3-4X PER DAY, PATIENT PREVIOUSLY STATED HE WANTED REVI IN ORDER TO NOT HAVE TO GO TO THE RESTROOM AS OFTEN WHEN FLYING HOME TO (B)(6).) THE PATIENT EXPERIENCED SWELLING THAT MAY OR MAY NOT BE RELATED TO THE DEVICE.

    Description of Event or Problem · 0

    PATIENT SWELLING FOLLOWING TREATMENT. FCS REPORTED :PATIENT REPORTS ANKLE SWELLING SOON AFTER USE OF THE DEVICE, AND SWELLING DOES NOT SUBSIDE FOR DAYS. PICTURES ARE SENT FROM PATIENT PROVIDED TO FCS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65927 REVI SYSTEM IMPLANTED TIBIAL ELECTRICAL URINARY CONTINENCE DEVICE QXM BLUEWIND MEDICAL LTD KA-9000-0001_US_CM 07290017912226

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Other