BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVI SYSTEM

    MDR report key: 22672220 · Received July 30, 2025

    Report

    Report Number
    3012239564-2025-00006
    Event Type
    Injury
    Date Received
    July 30, 2025
    Date of Event
    June 28, 2025
    Report Date
    July 30, 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. SURGICAL SITE INFECTION (SSI) - ALTHOUGH NO COMORBIDITIES ACKNOWLEDGED, THIS PATIENT SUFFERED FROM A SURGICAL SITE INFECTION. POSSIBLY COULD HAVE BEEN TREATED WITH REPEAT WOUND DEBRIDEMENT AND BANDAGING, AS THE PATIENT WAS PLANNING TO GO ON A CRUISE VACATION, HCP DECIDED IT IS MORE REASONABLE TO EXPLANT AS WOUND HANDLING WOUND NOT BE OPTIMAL DURING A CRUISE VACATION. SURGICAL SITE INFECTIONS ARE KNOWN AND EXPECTED EVENTS IN PATIENTS UNDERGOING FOOT AND ANKLE SURGERY. A RECENT REVIEW FOUND THE INCIDENCE OF SSI FOR PATIENT UNDERGOING FOOT AND ANKLE SURGERIES MAY BE UP TO 6.5% OF CASES. HTTPS://WWW.SCIENCEDIRECT.COM/SCIENCE/ARTICLE/ABS/PII/S0958259224000257.

    Description of Event or Problem · 0

    PATIENT STATES HE WENT TO THE ER (B)(6) DUE TO INFECTION AT THE INCISION SITE. HE WAS GIVEN ANTIBIOTICS AND SENT HOME TO SCHEDULE EXPLANT AS ER DOCTOR WAS HESITANT TO EXPLANT DUE TO PATIENT BEING ON BLOOD THINNERS. PATIENT CALLED TO INFORM HE IS BEING EXPLANTED (B)(6) AT 7:15AM BY DR. (B)(6). HE IS A PATIENT OF DR. (B)(6), BUT DR. (B)(6) IS OUT OF TOWN. ON (B)(6) 2025: PATIENT WAS EXPLANTED WITHOUT ISSUES; A CULTURE WAS TAKEN DUE TO ACTIVE INFECTION; PATIENT WAS GIVEN 7-DAY COURSE OF ANTIBIOTICS POST-SURGERY AND WILL FOLLOW UP IN CLINIC (B)(6) WITH (B)(6), DR. (B)(6) PA. PATIENT IS LEAVING FOR A CRUISE VACATION (B)(6). PATIENT WANTED TO TRY TO SALVAGE IMPLANT, BUT DR. (B)(6) THOUGHT BEST TO EXPLANT DUE TO PATIENT'S UPCOMING CRUISE. IMPLANT WAS COLLECTED IN A BIOHAZARD BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52520 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 76 YR Male Required Intervention| H