BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVI SYSTEM

    MDR report key: 22683327 · Received July 31, 2025

    Report

    Report Number
    3012239564-2025-00007
    Event Type
    Injury
    Date Received
    July 31, 2025
    Date of Event
    May 23, 2025
    Report Date
    July 31, 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

    THE PATIENT REPORTS A FEW USES OF THE DEVICE WITH A BURNING SENSATION AT THE INCISION SITE AND EXTENDING UP THE LEG, DESCRIBED AS ON-AND-OFF DURING AND AFTER TREATMENT. THE PROGRAM USED AND THE TREATMENT TIME OF MORE THAN 30 MINUTES COULD BE ONE OF THE CAUSES. THE PAIN, RATED AS A 3 ON A 1-10 SCALE, IS SUPERFICIAL, NOT DEEP IN THE ANKLE, AND ACCOMPANIED BY TINGLING IN THE FOOT'S SOLE DURING TREATMENTS. SHE DENIES ANY HISTORY OF NEUROPATHY. FOLLOWING (B)(6), 30-MINUTE SESSIONS WITH SUGGESTED PROGRAM SEEM WORKING.

    Description of Event or Problem · 0

    "SHE HAS BEEN FEELING "SLIGHT STINGING/BURN" AT IMPLANT SITE WHEN NOT TREATING THE "LAST COUPLE OF WEEKS, BUT IT HAS GOTTEN BETTER" "ANKLE SEEMS SWOLLEN AND YELLOW AROUND INCISION" SHE HAS JUST SEEN HER PCP WHO SAID THE INCISION DID NOT APPEAR INFECTED. I ASKED FOR PHOTO TO BE SENT TO MYSELF AND TO NOTIFY DR. FERULIC WITH CONCERNS AS WELL AS A PHOTO. I ASKED HER TO STOP TREATING HERSELF IF THE "STINGING/BURN" CONTINUES OR EXPERIENCING ANY DISCOMFORT. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2224137 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 77 YR Female Other