BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEOAR VUE

    MDR report key: 21142170 · Received January 10, 2025

    Report

    Report Number
    MW5164591
    Event Type
    Injury
    Date Received
    January 10, 2025
    Date of Event
    November 10, 2023
    Report Date
    January 8, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OVB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT HAD A SPACE OAR VUE - (B)(4) PLACED AND DEVELOPED COLO URETHRAL AND RECTOURETHRAL FISTULAS. THERE IS NO DEFINITIVE DATA TO PROVE THIS WAS THE CAUSE OF THE FISTULAS DEVELOPMENT BUT OUT OF AN ABUNDANCE OF CAUTION THIS PRODUCT IS NO LONGER BEING USED BY UROLOGY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2212044 SPACEOAR VUE HYDROGEL SPACER OVB BOSTON SCIENTIFIC CORPORATION 32596887

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Hospitalization