BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-SEAL CONTROL FMS KIT US

    MDR report key: 3915161 · Received May 15, 2014

    Report

    Report Number
    1049092-2014-00120
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    KNT
    PMA / PMN Number
    K112342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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. ATTEMPTS WERE MADE TO OBTAIN FURTHER INFORMATION BUT, NONE WAS AVAILABLE. CALL ATTEMPTS ARE AS FOLLOWS: 04/22/2014: 1ST. ATTEMPT, LEFT VOICEMAIL FOR COMPLAINANT; VOICEMAIL STATES OUT OF OFFICE UNTIL 04/28/2014. SPOKE WITH CONVATEC TERRITORY MANAGER AGAIN AND CONFIRMS NO OTHER CONTACT PERSON TO OBTAIN INFORMATION; 04/29/2014; 2ND ATTEMPT. VOICEMAIL LEFT FOR COMPLAINANT 1127 EST; 04/29/2014; ON 3RD. ATTEMPT COMPLAINANT RETURNED CALL INDICATING THAT NO FURTHER INFORMATION AVAILABLE AND PROVIDED NAME OF PRECEPTOR TO CONTACT AT (B)(4), LEFT VOICE MAIL FOR PRECEPTOR 1731 EST; 04/30/2014: 4TH ATTEMPT LEFT PRECEPTOR VOICEMAIL 1628 EST. COMPLAINANT CONFIRMED NO LOT NUMBER AVAILABLE, AND WAS UNABLE TO PROVIDE ANY FURTHER INFORMATION THAN ORIGINALLY REPORTED. 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. (B)(4). A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. (B)(4). 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 COMPLAINANT EXPERIENCED INFLATION DIFFICULTIES, BASED ON THE INABILITY TO INFLATE THE FMS BALLOON. REPORT ALSO STATES THAT THE PRESSURE INDICATOR WAS NOT WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289850 FLEXI-SEAL CONTROL FMS KIT US GASTROINTESTINAL TUBE AND ACCESSORIES KNT CONVATEC INC. 411107 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1