BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXI-SEAL SIGNAL

    MDR report key: 18621702 · Received February 1, 2024

    Report

    Report Number
    1049092-2024-00010
    Event Type
    Injury
    Date Received
    February 1, 2024
    Report Date
    January 24, 2024
    Manufacturer
    CONVATEC INC
    Product Code
    KNT
    UDI-DI
    00768455117178
    PMA / PMN Number
    K112342
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SEX: FEMALE BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. THIS COMPLAINT HAS BEEN EVALUATED. NO LOT NUMBER IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. 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

    CORRECTED DATA: D4: UDI# (B)(4). 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

    IT WAS REPORTED "WE RECENTLY HAD A PATIENT WHERE THE FLEXISEAL WAS UTILIZED FROM 12/24/2023 -1/6/2024. UPON DISCONTINUATION OF THE RECTAL TUBE THE PATIENT WAS NOTED TO HAVE INFARCTED TISSUE EXTRUDING FROM THE RECTUM AND ALSO DEVELOPED A RECTOVAGINAL FISTULA." THE DEVICE WAS INSERTED (B)(6) 2023 IN A FEMALE PATIENT WITH LIQUID STOOL. NO DETAILS ABOUT INSERTION OR PATIENT INFORMATION AVAILABLE. THE DEVICE WAS REMOVED (B)(6) 2024 AS THEY WANTED TO GIVE IMODIUM AND REMOVE THE DEVICE. UPON REMOVAL THE BEDSIDE NURSE NOTED NECROTIC TISSUE EXTRUDING FROM THE RECTUM. THE NURSE REPORTED 45CC OF FLUID IN BALLOON UPON REMOVAL. THE PATIENT REQUIRED SURGERY TO REMOVE THE NECROTIC TISSUE. DURING SURGERY THE SURGEON DISCOVERED A RECTOVAGINAL FISTULA HOWEVER HE RECOMMENDED REPAIR OF THE FISTULA AT A LATER TIME. THE SURGEON CONFIRMED WITH THE PATIENT AFTER REMOVAL THAT SHE HAD NO PREEXISTING ISSUES WITH THE RECTUM.

    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
    414902 FLEXI-SEAL SIGNAL TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CONVATEC INC 418000 00768455117178

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown