BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXI-SEAL PROTECT

    MDR report key: 17181572 · Received June 22, 2023

    Report

    Report Number
    1049092-2023-00179
    Event Type
    Injury
    Date Received
    June 22, 2023
    Report Date
    June 15, 2023
    Manufacturer
    CONVATEC INC
    Product Code
    EZQ
    UDI-DI
    00768455143016
    PMA / PMN Number
    K162906
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFFILIATION: (B)(6) HOSPITAL. 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. 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 "NO PR EXAM PRIOR TO INSERTION OF FMS; PATIENT WAS RESTLESS SO THE DEVICE WAS REMOVED AFTER ONLY 7 HOURS IN SITU. AFTER 21 DAYS POST REMOVAL, THE PATIENT WAS NOTED TO BE ADMITTED WITH CIRCUMFERENTIAL RECTAL NECROSIS, SUBSEQUENTLY REQUIRING TO HAVE A PERMANENT COLOSTOMY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1217767 FLEXI-SEAL PROTECT POUCH, COLOSTOMY EZQ CONVATEC INC 421630 00768455143016

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown