BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXI-SEAL PROTECT PLUS

    MDR report key: 22439046 · Received July 8, 2025

    Report

    Report Number
    1049092-2025-00204
    Event Type
    Injury
    Date Received
    July 8, 2025
    Report Date
    June 24, 2025
    Manufacturer
    CONVATEC
    Product Code
    KNT
    UDI-DI
    00768455157150
    PMA / PMN Number
    K190114
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER TO DATE NO NEW INFORMATION HAS BEEN RECEIVED. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED AS NO LOT NUMBER WAS PROVIDED. THEREFORE, THIS EVALUATION WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: 1049092. MANUFACTURING SITE: 8022978.

    Additional Manufacturer Narrative · 0

    CORRECTION H10: AS PER THE REQUEST RECEIVED FROM FDA ON 16 JUL 2025, IT WAS IDENTIFIED THAT THE RELATED REPORT NUMBER RECEIVED AS PER FDA MEDSUN MEDICAL DEVICE REPORT (MDR) NUMBER # (B)(4) WAS NOT ENTERED IN H10 (RELATED REPORT NUMBER) FIELD IN THE INITIAL EMDR. HENCE, IT HAS BEEN CORRECTED AND ENTERED ALONG WITH THIS FOLLOW EMDR REPORT 01. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: 1049092. MANUFACTURING SITE: 8022978.

    Description of Event or Problem · 0

    MEDWATCH REPORT # (B)(4) WAS RECEIVED FROM THE FDA. IT WAS REPORTED THAT A PATIENT WAS ADMITTED TO INTENSIVE CARE UNIT FOR METABOLIC ACIDOSIS AND SUBDURAL HEMATOMA. THE CIRRHOTIC PATIENT WITH A FECAL MANAGEMENT SYSTEM (BALLOON) DEVELOPED HEMORRHAGIC SHOCK REQUIRING MASSIVE TRANSFUSION PROTOCOL AND USE OF VASOPRESSORS FOR HEMODYNAMIC INSTABILITY. EGD [ESOPHAGOGASTRODUODENOSCOPY] WAS PERFORMED AT BEDSIDE AND PER DOCTOR, PT BLEEDING WAS RELATED TO FECAL CONTAINMENT DEVICE THAT CAUSE ULCERATION AND ARTERIAL BLEEDING. THE PATIENT SUBSEQUENTLY REQUIRED AN ADDITIONAL 4 UNITS PRBCS [PACKED RED BLOOD CELLS] AND UP TITRATION OF LEVOPHED FOR HEMODYNAMIC INSTABILITY POST EGD FOR CONTINUED BRBPR [BRIGHT RED BLOOD PER RECTUM]. NO ADDITIONAL INFORMATION WAS PROVIDED. NO PHOTOS AVAILABLE.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2071674 FLEXI-SEAL PROTECT PLUS TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CONVATEC 422303 00768455157150

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male