BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVI¿ WEARABLE DEVICE

    MDR report key: 22639873 · Received July 28, 2025

    Report

    Report Number
    3012239564-2025-00005
    Event Type
    Malfunction
    Date Received
    July 28, 2025
    Date of Event
    June 28, 2025
    Report Date
    July 28, 2025
    Manufacturer
    BLUEWIND MEDICAL LTD
    Product Code
    QXM
    UDI-DI
    07290017912028
    PMA / PMN Number
    K240037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLUEWIND MEDICAL IS PROVIDING THIS REPORT IN COMPLIANCE WITH FDA 21CFR PART 803. THE DEVICE WAS REPLACED. AS A RESULT, A DESIGN HISTORY RECORD REVIEW WAS PERFORMED AND REVIEW OF LOG FROM REMOTE USAGE. WHILE REVIEW OF DESIGN CONTROL DOCUMENT AND ASSOCIATED RISKS, LABELING AND OTHER INFORMATION FROM REMOTE LOG OF PATIENT DEVICE WERE REVIEWED AND CAUSE WAS NOT ESTABLISHED OR PROBLEM COULD BE WITH THE DEVICE BUT UNTIL IT IS RETURNED FOR INVESTIGATION. THE LABELING IDENTIFIED THE ADVERSE EVENT AND CAUTION STATEMENT RELATED TO THE HOT SURFACE DUE TO BATTERY IS ADEQUATE.

    Description of Event or Problem · 0

    ECU CHARGER MALFUNCTION - PATIENT SAID 2 DAYS AGO WHEN HER DEVICE WAS ON THE CHARGER, IT GOT SO HOT TO THE POINT SHE COULD NOT TOUCH IT. SHE IS VERY CONCERNED THAT IT WILL KEEP HAPPENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1476013 REVI¿ WEARABLE DEVICE IMPLANTED TIBIAL ELECTRICAL URINARY CONTINENCE DEVICE QXM BLUEWIND MEDICAL LTD MA-1004-0500 07290017912028

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Other