BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXI- SEAL

    MDR report key: 24873818 · Received April 14, 2026

    Report

    Report Number
    1049092-2026-00080
    Event Type
    Injury
    Date Received
    April 14, 2026
    Report Date
    March 19, 2026
    Product Code
    KNT
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. 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

    A TERRITORY MANAGER REPORTS MULTIPLE INCIDENTS (4) THAT HAVE OCCURRED OVER THE LAST SEVERAL WEEKS. "BLEEDING AND FISTULAS, 4 SIGNIFICANT EVENTS, ONE WORKED ITS WAY UP TO THE COLON. THESE HAVE HAPPENED OVER THE LAST SEVERAL WEEKS." MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE. AS OF THIS DATE, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. NO PHOTO IS AVAILABLE. THIS REPORT REPRESENTS: INCIDENT 2 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940649 FLEXI- SEAL UNKNOWN KNT CCC-UNKNOWN FMS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown