BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVI SYSTEM

    MDR report key: 20027277 · Received August 22, 2024

    Report

    Report Number
    3012239564-2024-00001
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    July 20, 2024
    Report Date
    August 16, 2024
    Manufacturer
    BLUEWIND MEDICAL LTD
    Product Code
    QXM
    UDI-DI
    07290017912011
    PMA / PMN Number
    K240037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLUEWIND MEDICAL IS PROVIDING THIS REPORT IN COMPLIANCE WITH FDA 21CFR PART 803. THE DEVICE WAS EXPLANTED; HOWEVER, NO EXPLANTED PRODUCT WAS RETURNED FOR ANALYSIS. AS A RESULT, A DESIGN HISTORY RECORD REVIEW WAS PERFORMED TO CONFIRM THE STERILITY OF THE IMPLANT. BASED ON THE DOCUMENTS REVIEWED AND THE INTERVIEWS WITH PHYSICIANS, THE INFECTION WAS SUPERFICIAL AND NOT A DEEP INFECTION THAT INVOLVED THE IMPLANT.

    Description of Event or Problem · 0

    PATIENT REPORTED OPEN WOUND AT INCISION SITE WITH DRAINAGE. THE TREATING PHYSICIAN DETERMINED THERE WERE SIGNS OF INFECTION AND THE FOLLOWING ACTIONS WERE TAKEN: A WOUND CULTURE WAS COMPLETED AND SHOWED 2 STRAINS OF PSEUDOMONAS AERUGINOSA. THE PATIENT WAS PRESCRIBED BACTRIM. THE PHYSICIAN REMOVED THE IMPLANT ON (B)(6) 2024 UNDER IV SEDATION. THE PATIENT IS CURRENTLY RECOVERING WITH NO LONG-TERM COMPLICATIONS ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2178749 REVI SYSTEM IMPLANTED TIBIAL ELECTRICAL URINARY CONTINENCE DEVICE QXM BLUEWIND MEDICAL LTD MA-1007-0600_US_CM N/A 07290017912011

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention COSOPT 1 DROP QD FOR GLAUCOMA| GEMTESA 75MG PO FOR UUI/OAB| ROCKLATAN 1 DROP FOR GLAUCOMA| SYNTHROID 125MCG PO FOR THYROID DISEASE