BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPROTECT BALLOON IMPLANT SYSTEM

    MDR report key: 23274211 · Received October 12, 2025

    Report

    Report Number
    3014285231-2025-00010
    Event Type
    Injury
    Date Received
    October 12, 2025
    Date of Event
    September 16, 2025
    Report Date
    October 11, 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 DURING DIGITAL RECTUM EXAM A SMALL AMOUNT OF BLOOD WAS OBSERVED. ALTHOUGH NO RECTAL TEAR WAS OBSERVED, THE PHYSICIAN PUT A SUTURE IN A RECTAL WALL AREA THAT FELT VULNERABLE AND THIN. HE THEN ASPIRATED THE BALLOON FOR PRESSURE RELIEF AND LEFT IT IN SITU. THE PATIENT WAS DISCHARGED THE SAME DAY. THE PATIENT WILL START HIS RADIATION TREATMENT AS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2791473 BIOPROTECT BALLOON IMPLANT SYSTEM BIOPROTECT BALLOON IMPLANT SYSTEM OVB BIOPROTECT LTD. 7290014878020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention