BEUDAMED
    FDA Adverse Event Other Summary report: N

    FLEXI-SEAL FMS

    MDR report key: 640414 · Received October 11, 2005

    Report

    Report Number
    1049092-2005-00050
    Event Type
    Other
    Date Received
    October 11, 2005
    Date of Event
    September 12, 2005
    Report Date
    September 12, 2005
    Manufacturer
    CONVATEC
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS ADMITTED TO THE HOSP WITH DIAGNOSES OF CELLULITIS AND SEPSIS. THE FMS SYSTEM WAS INSERTED INTO FEMALE IN AN ACUTE CARE FACILITY TO MANAGE INCONTINENCE WHILE ATTEMPTING TO HEAL A PRESSURE SORE ON THE BUTTOCKS. THE FMS WAS PLACED IN 08/2005 AND THEN THE PT WAS MOVED TO A SUB-ACUTE FACILITY A FEW DAYS LATER. THE PT WAS RETURNED TO ACUTE CARE FACILITY WITHIN THE LAST FEW DAYS WHERE IT WAS OBSERVED THAT SHE HAD BLEEDING AROUND THE FMS TUBE. THE BALLOON WAS DEFLATED TO FACILITATE REMOVAL OF THE FMS, 110 CC'S OF WATER WAS REMOVED FROM THE BALLOON. THE FLEXISEAL DEVICE WAS IN PLACE WHEN THE PT WAS TRANSFERRED BACK TO SUB-ACUTE FACILITY. UPON READMISSIN TO ACUTE CARE FACILITY THE CLINICIAN WHO REMOVED THE DEVICE REPORTED WITHDRAWING 110ML FROM THE BALLOON. THE PT HAS UNDERGONE AN ANTERIOR RESECTION OF THE RECTUM WITH SIGMOID COLOSTOMY, IS CURRENTLY IN ICU AND STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXI-SEAL FMS FECAL MANAGEMENT SYSTEM KNT CONVATEC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other