BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXI-SEAL OTHERS

    MDR report key: 21102604 · Received January 8, 2025

    Report

    Report Number
    1049092-2025-00004
    Event Type
    Injury
    Date Received
    January 8, 2025
    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: SPAULDING CAMBRIDGE. 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 "PATIENT WITH ENCEPHALITIS, NOW WITH C. DIFF, RECTAL TUBE STARTED DUE TO INCREASED MASD AND NEW STAGE 3 PRESSURE INJURY TO SACRUM. MUCOSAL ULCER FOUND AFTER 1 WEEK OF FLEXISEAL IN PLACE. TUBE WAS DISCONTINUED; MUCOSAL ULCER NOW HEALED. 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
    1036561 FLEXI-SEAL OTHERS UNKNOWN KNT CONVATEC INC CCC-UNKNOWN FMS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown