BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACE OAR VUE SYSTEM 10ML

    MDR report key: 22469855 · Received July 10, 2025

    Report

    Report Number
    MW5172523
    Event Type
    Malfunction
    Date Received
    July 10, 2025
    Date of Event
    December 31, 2024
    Report Date
    July 7, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OVB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHEN PRODUCT WAS OPENED FOR USE, PHYSICIAN NOTICED THE CLEAR PART OF THE SYRINGE WAS CLOUDY. PRODUCT NOT USED ON PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894798 SPACE OAR VUE SYSTEM 10ML HYDROGEL SPACER OVB BOSTON SCIENTIFIC CORPORATION SV-2101 34830541

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown