BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPROTECT BALLOON IMPLANT SYSTEM OVB

    MDR report key: 19674840 · Received July 4, 2024

    Report

    Report Number
    3014285231-2024-00002
    Event Type
    Injury
    Date Received
    July 4, 2024
    Date of Event
    June 13, 2024
    Report Date
    July 4, 2024
    Manufacturer
    BIOPROTECT LTD.
    Product Code
    OVB
    UDI-DI
    7290014878020
    PMA / PMN Number
    K222972
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED TO BIOPROTECT LTD ON 14-JUN-2024 THAT THE BIOPROTECT BALLOON IMPLANT SYSTEM WAS IMPLANTED DURING PROCEDURE PERFORMED ON (B)(6) 2024. AFTER PROCEDURE COMPLETION, THE PATIENT HAD A BLEEDING IN THE RECTUM. THE PATIENT HAD A GLEASON 9 AND AN OBSCURE ANATOMY WITH A THIN TISSUE PROXIMAL TO THE ANAL VERGE, AND PERHAPS A PREEXISTING ANATOMICAL ANOMALY RESULTING IN A SMALL LESS THAN 5 MM HOLE IN THE RECTUM. THE DEVICE WAS EASY TO DEFLATE AND REMOVE TO ALLOW THIS HOLE TO HEAL. THE SMALL PERFORATION WAS SUTURED, AND BROAD-SPECTRUM ANTIBIOTIC WAS ADMINISTERED (ROCEPHIN). THE PATIENT WAS DISCHARGED HOME THE SAME DAY IN GOOD CONDITION. THE PATIENT WAS PLANNED FOR RADIOTHERAPY TREATMENT IT IS UNKNOWN IF IT WAS DELAYED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182465 BIOPROTECT BALLOON IMPLANT SYSTEM OVB Hydrogel spacer OVB BIOPROTECT LTD. 7290014878020

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention