BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPROTECT BALLOON IMPLANT SYSTEM

    MDR report key: 22990221 · Received September 8, 2025

    Report

    Report Number
    3014285231-2025-00009
    Event Type
    Injury
    Date Received
    September 8, 2025
    Date of Event
    August 13, 2025
    Report Date
    September 8, 2025
    Manufacturer
    BIOPROTECT LTD.
    Product Code
    OVB
    UDI-DI
    7290014878020
    PMA / PMN Number
    K222972
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED TO BIOPROTECT LTD. ON (B)(6) 2025 THAT A BIOPROTECT BALLOON IMPLANTATION PROCEDURE WAS PERFORMED ON (B)(6) 2025 AND COMPLETED AS EXPECTED. FOLLOWING THE PROCEDURE, THE PATIENT COMPLAINED OF NOT BEING ABLE TO VOID URINE. A FOLEY CATHETER WAS PLACED AND THE PATIENT WAS DISCHARGED. THE CATHETER WAS REMOVED ON (B)(6) 2025, AND THE SYMPTOMS WERE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2495901 BIOPROTECT BALLOON IMPLANT SYSTEM BIOPROTECT BALLOON IMPLANT SYSTEM OVB BIOPROTECT LTD. 7290014878020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention