BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPROTECT BALLOON IMPLANT SYSTEM

    MDR report key: 23837819 · Received December 18, 2025

    Report

    Report Number
    3014285231-2025-00015
    Event Type
    Injury
    Date Received
    December 18, 2025
    Date of Event
    November 21, 2025
    Report Date
    December 18, 2025
    Manufacturer
    BIOPROTECT LTD.
    Product Code
    OVB
    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. THE PROCEDURE WAS DONE UNDER GENERAL ANESTHESIA FOLLOWING PLACEMENT OF FIDUCIAL MARKERS. SEVERAL DAYS AFTER THE PROCEDURE THE PATIENT EXPERIENCED URINE VOIDING DIFFICULTIES, A FOLEY CATHETER WAS PLACED AND REMOVED AFTER A FEW DAYS, AFTER WHICH THE SYMPTOMS WERE RESOLVED. ON (B)(6) 2025 THE PLANNING CT AND MRI SCANS SHOWED HEMATOMA, AND THE PATIENT REPORTED A SENSATION OF CONSTIPATION. IT WAS DECIDED TO REPEAT THE CT IN A COUPLE OF WEEKS TO MONITOR THE HEMATOMA SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2246396 BIOPROTECT BALLOON IMPLANT SYSTEM BIOPROTECT BALLOON IMPLANT SYSTEM OVB BIOPROTECT LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention