BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVI SYSTEM

    MDR report key: 22542664 · Received July 18, 2025

    Report

    Report Number
    3012239564-2025-00003
    Event Type
    Injury
    Date Received
    July 18, 2025
    Date of Event
    June 20, 2025
    Report Date
    July 18, 2025
    Manufacturer
    BLUEWIND MEDICAL LTD.
    Product Code
    QXM
    UDI-DI
    07290017912011
    PMA / PMN Number
    K240037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BLUEWIND MEDICAL IS PROVIDING THIS REPORT IN COMPLIANCE WITH FDA 21CFR PART 803. PATIENT FEELING PAIN MAY BE CAUSED DUE TO THE IMPLANT FUNCTIONALITY FAILURE. AS A RESULT, A DESIGN HISTORY RECORD REVIEW WAS PERFORMED TO CONFIRM THE STERILITY OF THE IMPLANT. SIMILAR FAILURES FROM THE PAST WERE REVIEWED AND PATIENT IS BEING OFFERED A FREE REPLACEMENT-THE INITIAL REQUEST WAS SENT TO THE HCP.

    Description of Event or Problem · 0

    PATIENT CALLED TO REPORT FOR THE PAST FEW WEEKS WHEN SHE INITIATES TREATMENT, SHE GETS A "BOLT OF PAIN", SUFFICIENTLY UNCOMFORTABLE SHE HAS STOPPED USING THE DEVICE. THE PROBLEM BEGAN ABOUT SIX WEEKS AGO; SHE COULD NOT THINK OF ANY CHANGE OR EVENT THAT MIGHT HAVE PRECIPITATED THE PROBLEM. PS ADVISED HER TO STOP USING THE WEARABLE WHILE THE BLUEWIND MEDICAL INVESTIGATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1195567 REVI SYSTEM IMPLANTED TIBIAL ELECTRICAL URINARY CONTINENCE DEVICE QXM BLUEWIND MEDICAL LTD. MA-1007-0600_US_CM 07290017912011

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female Other