BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVI SYSTEM

    MDR report key: 22779259 · Received August 11, 2025

    Report

    Report Number
    3012239564-2025-00008
    Event Type
    Injury
    Date Received
    August 11, 2025
    Date of Event
    July 11, 2025
    Report Date
    August 11, 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

    MEDICAL INVESTIGATION - WOUND INCISION SHOWS SCABBING WITH NO PURULENT DISCHARGE. THE PHOTO OF THE WOUND SHOWS A RECTANGULAR SKIN REACTION COMPATIBLE WITH THE SKIN REACTION TO THE WOUND DRESSING. WE BELIEVE EXPLANTATION DECISION MADE BY THE PATIENT AND HCP WAS AFTER A LONG TIME OF DELAYED WOUND HEALING AND WAS LEGITIMATE, BUT POSSIBLY REMOVING THE BANDAGE, WHICH MAY HAVE CAUSED THE WOUND HEALING ISSUES. DISCUSSION WITH PROF. DMOCHOWSKI (CMO) - NO EVIDENCE OF INFECTION - SUSPECTED ALLERGIC REACTION TO WOUND DRESSING.

    Description of Event or Problem · 0

    REPORTED AS DELAYED HEALING. THE PHOTO SHOWS SCABBING OF THE WOUND. THERE HAVE BEEN SIGNS OF IMPROVEMENT AT TIMES; HOWEVER, THE IMPROVEMENT HAS OFTEN BEEN SHORT-LIVED, AND THE INFECTION HAS RETURNED EVEN AFTER MULTIPLE ROUNDS OF ANTIBIOTICS. EXPLANATION COMPLETED. DURING THE EXPLANTATION, IT DID NOT APPEAR THAT THE ACTUAL IMPLANT WAS INFECTED WHEN TAKEN OUT, AND IT WAS FULLY ENCAPSULATED. DATE OF EXPLANT ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1379006 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 NA Female Hospitalization