BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPROTECT BALLOON IMPLANT SYSTEM

    MDR report key: 22663677 · Received July 30, 2025

    Report

    Report Number
    3014285231-2025-00006
    Event Type
    Injury
    Date Received
    July 30, 2025
    Date of Event
    July 3, 2025
    Report Date
    July 30, 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. FOLLOWING PROCEDURE COMPLETION, THE PATIENT REPORTED ON DISCOMFORT IN THE PERINEAL AREA. THE PHYSICIAN ASPIRATED THE BALLOON TO RELIEVE THE PATIENT'S SYMPTOMS. MAGNETIC RESONANCE IMAGING (MRI) FOLLOWING BALLOON ASPIRATION CONFIRMED NO INJURY AND DID NOT IDENTIFY ANY POSSIBLE CAUSE TO THE PERINEAL PAIN. FEW DAYS LATER, THE PATIENT WAS ADMITTED TO THE HOSPITAL AND TREATED WITH IV ANTIBIOTICS FOR CYSTITIS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444538 BIOPROTECT BALLOON IMPLANT SYSTEM BIOPROTECT BALLOON IMPLANT SYSTEM OVB BIOPROTECT LTD. 7290014878020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization