BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPROTECT BALLOON IMPLANT SYSTEM

    MDR report key: 24196439 · Received January 27, 2026

    Report

    Report Number
    3012602431-2026-00012
    Event Type
    Injury
    Date Received
    January 27, 2026
    Date of Event
    November 17, 2025
    Report Date
    January 27, 2026
    Manufacturer
    BIOPROTECT LTD
    Product Code
    OVB
    UDI-DI
    7290014878020
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    MFR REPORT #: 3014285231-2025-00013. IT WAS REPORTED TO BIOPROTECT LTD. ON (B)(6) 2025 THAT A BIOPROTECT BALLOON IMPLANTATION PROCEDURE WAS PERFORMED. THE PROCEDURE WAS DONE UNDER GENERAL ANESTHESIA FOLLOWING PLACEMENT OF FIDUCIAL MARKERS AND WAS COMPLETED AS EXPECTED. FOLLOWING THE PROCEDURE, THE PATIENT COMPLAINED OF NOT BEING ABLE TO VOID URINE. THE PATIENT WAS PRESCRIBED WITH FLOMAX AND IBUPROFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256174 BIOPROTECT BALLOON IMPLANT SYSTEM Hydrogel spacer OVB BIOPROTECT LTD 7290014878020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other