BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXI-SEAL OTHERS

    MDR report key: 21102603 · Received January 8, 2025

    Report

    Report Number
    1049092-2025-00003
    Event Type
    Injury
    Date Received
    January 8, 2025
    Report Date
    December 12, 2024
    Manufacturer
    CONVATEC INC
    Product Code
    KNT
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFFILIATION: (B)(6). 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.

    Description of Event or Problem · 0

    IT WAS REPORTED "VENT DEPENDENT PATIENT WITH A RECURRENT MUCOSAL PRESSURE INJURY. ANAL MUCOSAL ULCER PRESENT ON ADMISSION, HAD HEALED IN ABSENCE OF RECTAL TUBE; HE NOW HAS C. DIFF AGAIN AND SO WE RESTARTED RECTAL TUBE AND ULCER RECURRED. INDICATION FOR FLEXISEAL IS FREQUENT STOOLING WITH NEARBY SACRAL STAGE 4 PRESSURE INJURY, SO WE HAVE CONTINUED THE FLEXISEAL DESPITE THE RECURRENT ULCER. THESE ARE ALL EXTERNAL, E.G., AT THE ANAL VERGE AND NOT INSIDE THE RECTUM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1036560 FLEXI-SEAL OTHERS UNKNOWN KNT CONVATEC INC CCC-UNKNOWN FMS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown