BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT

    MDR report key: 3813474 · Received March 31, 2014

    Report

    Report Number
    2243969-2014-00150
    Event Type
    Malfunction
    Date Received
    March 31, 2014
    Date of Event
    March 6, 2014
    Report Date
    March 6, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PATIENT BEING HARMED AS A RESULT OF THIS MALFUNCTION. INFORMATION REFERENCED VIA EMAIL IS INDICATED AS FOLLOWS: THE NURSES REPORTED THAT THEY HAVE HAD TWO SITUATIONS WHERE THE FLEX-SEAL BALLOON WOULD NOT DEFLATE. BOTH INSTANCES OCCURRED IN PATIENTS THAT WERE DECEASED SO REMOVAL WAS NOT AN ISSUE. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE LOT NUMBER WAS NOT PROVIDED. THEREFORE, WE ARE UNABLE TO DETERMINE THE SPECIFIC MANUFACTURING SITE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. PLEASE NOTE: EVENT DESCRIPTION REFERENCES "TWO (2) DIFFERENT DEVICES WOULD NOT DEFLATE" THEREFORE; A SEPARATE 3500A FORM HAS BEEN COMPLETED FOR THE OTHER CASE UNDER PATIENT IDENTIFIER#: 332920 AND MFR. REPORT#: 2243969-2014-00149. (THIS IS REPORT 2 OF 2 TO CAPTURE THESE CASES). CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S. COMPLAINT HANDLING AND CAPA PROCEDURES.

    Description of Event or Problem · 1

    COMPLAINANT EXPERIENCED DEFLATION DIFFICULTIES BASED ON BASED ON A REPORT THAT THE BALLOON DOESN'T DEFLATE, THE SAME ISSUE OCCURRED WITH TWO (2) DIFFERENT DEVICES IN PATIENT'S THAT HAD ALREADY EXPIRED FROM UNSPECIFIED MEDICAL CAUSES UNRELATED TO THE FMS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189856 FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT GASTROINTESTINAL TUBE AND ACCESSORIES KNT CONVATEC INC. 418000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1