BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROVAC BLADDER EVACUATOR

    MDR report key: 22962258 · Received September 4, 2025

    Report

    Report Number
    2124215-2025-62060
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    August 7, 2025
    Report Date
    September 4, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FFD
    UDI-DI
    08714729033769
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCKS D4, H4: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UDI AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK H6: DEVICE CODE A180104 CAPTURES THE REPORTABLE EVENT OF FOREIGN MATERIAL PRESENT IN THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A UROVAC DEVICE WAS USED DURING A PROCEDURE. REPORTEDLY, IT WAS NOTICED THAT A FOREIGN MATTER WAS MIXED IN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2331247 UROVAC BLADDER EVACUATOR EVACUATOR, BLADDER, MANUALLY OPERATED FFD BOSTON SCIENTIFIC CORPORATION M0067301251 08714729033769

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown