BEUDAMED
    FDA Adverse Event Other Summary report: N

    FLEXI-SEAL FMS

    MDR report key: 725630 · Received June 7, 2006

    Report

    Report Number
    1049092-2006-00003
    Event Type
    Other
    Date Received
    June 7, 2006
    Date of Event
    May 4, 2006
    Report Date
    May 8, 2006
    Manufacturer
    CONVATEC
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLETED PRODUCT INVESTIGATIN: NO LOT NUMBER WAS STATED IN THIS CASE REPORT, SO A 12 MONTHS REVIEW OF FLEXI-SEAL FMS KIT BATCH RECORDS, FOR PRODUCT PRODUCED PRIOR TO CASE REPORT DATE (5/08/06), WAS CONDUCTED. THE BATCH RECORDS WERE ALL WITHIN COMPLIANCE TO MT61-011. THERE WERE NO NON-CONFORMANCES OR CAPA'S IDENTIFIED. NO TRENDS OR IRREGULAR BEHAVIORS WERE OBSERVED. 510(K) # IS K032734.

    Description of Event or Problem · 1

    NURSE INDICATES PATIENT IS MALE, KNOWN TO THEIR FACILITY AND HAD SACRAL PRESSURE ULCER. NURSE WAS CALLED TO BEDSIDE TO HELP CONTROL HIS COPIOUS LIQUID STOOL OUTPUT WHICH WAS CONSTANTLY SOILING THE PRESSURE ULCER. NURSE INDICATED HIS PRESSURE ULCER HAD ESCHAR, LOOSE AND "SOUPY" AT THE EDGES. NURSE HAD ATTENDED THE FLEXI-SEAL FMS IN-SERVICE PROVIDED BY CONVATEC SALES REPRESENTATIVE AND KNEW TO DO A DIGITAL RECTAL EXAM BEFORE CONSIDERING USE OF THE FMS DEVICE. SHE INDICATES REMEMBERING AS SHE CONDUCTED THE DIGITAL EXAM THAT SHE WONDERED IF PATIENT HAD ENOUGH RECTAL TONE TO HOLD THE DEVICE. SHE INSERTED THE FMS 06 WHEN PATIENT FIRST BECAME ANEMIC, BUT WAS TRANSFERRED TO ICU PROBABLY ON THURSDAY OF THE DAY OF EVENT WITH GI BLEED AND SHE THINKS FMS REMOVED THAT MORNING. REPORT OF ENDOSCOPIC EXAM NOT AVAILABLE, BUT BY REPORT OF ICU NURSES, INDIVIDUAL HAD RECTAL ULCERATION WHICH DID NOT REQUIRE SURGICAL INTERVENTION. PATIENT WAS TRANSFERRED OUT OF ICU BACK TO MEDICAL UNIT SUNDAY, 2006 AND REMAINS THERE WITH NO FURTHER EVIDENCE OF RECTAL BLEEDING.

    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 72 YR Other