BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXI-SEAL OTHERS

    MDR report key: 21102602 · Received January 8, 2025

    Report

    Report Number
    1049092-2025-00001
    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 STAGE 4 TO RIGHT ISCHIUM, RECENTLY WITH INCREASED RESPIRATORY DISTRESS/CHALLENGES WITH POSITIONAL TRACH, RECTAL TUBE STARTED TO PROTECT WOUND AND TO MINIMIZE NEED FOR SIDE-LYING DURING HYGIENE & DRESSING CHANGES- MUCOSAL ULCER NOTED AFTER 1 MONTH OF FLEXISEAL. THESE ARE ALL EXTERNAL, E.G., AT THE ANAL VERGE AND NOT INSIDE THE RECTUM." NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1036559 FLEXI-SEAL OTHERS UNKNOWN KNT CONVATEC INC CCC-UNKNOWN FMS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown