BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVI SYSTEM

    MDR report key: 22581828 · Received July 23, 2025

    Report

    Report Number
    3012239564-2025-00004
    Event Type
    Injury
    Date Received
    July 23, 2025
    Date of Event
    June 16, 2025
    Report Date
    June 23, 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

    (B)(6) IS PROVIDING THIS REPORT IN COMPLIANCE WITH FDA 21CFR PART 803. BASED ON THE DISCUSSION ABOUT THE ADVERSE EVENT, PATIENT HISTORY, PRIOR COMPLAINTS AND REVIEW OF LABELING CONCLUDES NO IMPACT OF FUNCTIONALITY OF THE IMPLANT AND THIS ADVERSE EVENT IS CAUSED DUE TO NOT FOLLOWING THE WARNING MENTIONED IN THE LABELING. PATIENT SHOULD NOT USE REVI WEARABLE UNIT IN THE COMPROMISED AREA WHERE SHE NOTICED SOME ACUTE SORENESS.

    Description of Event or Problem · 0

    PT REPORTS SHE WORKS AT A PRESCHOOL AND WHILE PLAYING ON THE FLOOR WITH CHILDREN, THEY STEPPED ON HER LEG NEAR THE AREA OF HER IMPLANT. SHE REPORTED SOME ACUTE SORENESS IN THE AREA BUT INITIALLY NO PAIN WITH STIMULATION (THIS WAS ABOUT A WEEK AGO). THIS MORNING FCS RECEIVED A TEXT FROM THE PATIENT REPORTING DIFFICULTY CONNECTING THE WEARABLE TO HER IMPLANT AND SEVERE PAIN WITH STIMULATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57907 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 21 YR Female Other