BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPROTECT BALLOON IMPLANT SYSTEM

    MDR report key: 24843227 · Received April 10, 2026

    Report

    Report Number
    3014285231-2026-00008
    Event Type
    Injury
    Date Received
    April 10, 2026
    Date of Event
    February 27, 2026
    Report Date
    April 10, 2026
    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. THAT A BIOPROTECT BALLOON IMPLANTATION PROCEDURE WAS PERFORMED ON (B)(6) 2026. A PLANNING MRI PERFORMED APPROXIMATELY 2 WEEKS AFTER THE PROCEDURE SUGGESTED THAT THE BALLOON WAS POSITIONED WITHIN THE RECTUM. THE BALLOON WAS SUBSEQUENTLY ASPIRATED. THE PATIENT DID NOT PRESENT ANY CLINICAL SYMPTOMS, AND NO MUCOSAL COMPROMISE WAS IDENTIFIED ON DIGITAL RECTAL EXAMINATION (DRE). THE PATIENT IS SCHEDULED TO UNDERGO SIGMOIDOSCOPY. THE COMPANY WILL SUPPLEMENT THIS MDR SHOULD ANY ADDITIONAL INFORMATION BE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906490 BIOPROTECT BALLOON IMPLANT SYSTEM BIOPROTECT BALLOON IMPLANT SYSTEM OVB BIOPROTECT LTD. 7290014878020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other