BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXI-SEAL SIGNAL (FMS) SYSTEM WITH ZEOLITE

    MDR report key: 5904375 · Received August 25, 2016

    Report

    Report Number
    1049092-2016-00381
    Event Type
    Death
    Date Received
    August 25, 2016
    Date of Event
    August 4, 2016
    Report Date
    August 5, 2016
    Manufacturer
    CONVATEC INC.
    Product Code
    KNT
    PMA / PMN Number
    K150350
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. BASED ON INFORMATION PROVIDED, NO PATIENT HARM OCCURRED. ADDITIONAL DETAILS HAVE BEEN REQUESTED BUT HAVE NOT BEEN RECEIVED TO DATE. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    A BATCH RECORD REVIEW INDICATES NO DISCREPANCIES. REVIEW OF FOUR RETAIN SAMPLES (4 FMS DEVICES) FOR LOT# 16FM0404 SHOWS THAT THE APPEARANCE OF THE BALLOON/INFLATION PORT, CATHETER BODY AND VALVE FUNCTION ARE NORMAL. COMPLAINT SIMULATION TESTING OF FOUR RETAIN SAMPLES (4 FMS DEVICES) FOR LOT# 16FM0404 SHOWS THAT NO LEAKAGE, DAMAGE OR OCCLUSION OCCURS WHEN IRRIGATING. THEREFORE, THE IRRIGATION PORT TUBING OF THE DEVICES WORKS PROPERLY. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON OCTOBER 13, 2016. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "IRRIGATED TUBE AND PLUS TUBE IS LEAKING AFTER THE DEVICE WAS INSERTED ON (B)(6)." ADDITIONAL FOLLOW-UP REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED FOUR (4) DAYS PRIOR TO THE DEVICE INSERTION, WITH DECREASED LEVEL OF CONSCIOUSNESS (LOC). THE DEVICE WAS PLACED TO MANAGE DIARRHEA AND PROTECT EXISTING PERINEAL SKIN BREAKDOWN. THE DEVICE WAS IN PLACE FROM (B)(6) 2016. THE DEVICE WAS IRRIGATED EVERY 12 HOUR SHIFT AS ROUTINE MAINTENANCE. THE DEVICE WAS FOUND TO LEAK AND WAS DISCONTINUED, REMOVED AND WAS NOT REPLACED WITH ANY OTHER DEVICE. THERE WERE NO ADVERSE EFFECTS FOR THE PATIENT NOTED, HOWEVER A CRACK WAS FOUND IN THE TUBING BETWEEN THE IRRIGATION PORT AND THE BALLOON. THE PATIENT HAD NO DISCOMFORT OR PAIN AND DID NOT REQUIRE ANY MEDICAL, SURGICAL OR INTERVENTION. THE PATIENT LATER EXPIRED/DIED ON (B)(6) 2016 AND THE CAUSE OF DEATH WAS NOT DISCLOSED. NO FURTHER DETAILS HAVE BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557091 FLEXI-SEAL SIGNAL (FMS) SYSTEM WITH ZEOLITE TUBES, GASTROINTESTINAL & ACCESSORIES KNT CONVATEC INC. 418000 16FM0404

    Patients

    Seq Age Sex Outcome Treatment
    1 Death