BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT

    MDR report key: 4162881 · Received July 16, 2014

    Report

    Report Number
    1049092-2014-00304
    Event Type
    Malfunction
    Date Received
    July 16, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    CONVATEC INC
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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. IT IS REPORTED THAT THE HOSPITAL RECENTLY TRANSITIONED FROM CONTROL TO SIGNAL. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. SHOULD ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. PLEASE NOTE: (B)(4) PRODUCTS WERE AFFECTED; THEREFORE A SEPARATE FDA FORM 3500A HAS BEEN GENERATED TO ADDRESS THE OTHER (B)(4) CASES REPORTED UNDER PATIENT IDENTIFIER# (S) (B)(4). THE LOT NUMBER WAS NOT PROVIDED. THEREFORE, WE ARE UNABLE TO DETERMINE THE SPECIFIC MANUFACTURING SITE. BOTH POTENTIAL MANUFACTURING SITE NUMBERS ARE LISTED BELOW. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. REPORTED TO THE FDA ON (B)(4) 2014. NOTE: THE ACTUAL DATE OF EVENT IS UNKNOWN, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE. 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

    IT IS REPORTED THAT LEAKAGE CONTINUES AROUND THE BALLOON CREATING ADDITIONAL SKIN ISSUES AND DISCOMFORT FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416422 FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT GASTROINTESTINAL TUBE & ACCESSORIES KNT CONVATEC INC 418000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1