BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXI-SEAL CONTROL FMS KIT US

    MDR report key: 3788412 · Received April 29, 2014

    Report

    Report Number
    2243969-2014-00204
    Event Type
    Injury
    Date Received
    April 29, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 4, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    KNT
    PMA / PMN Number
    K112342
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. THERE IS NO OTHER INFORMATION AVAILABLE AT THIS TIME, INCLUDING THE TYPE OF SURGERY, THE OUTCOME OR THE PT'S MEDICAL HISTORY. LOT NUMBER IS NOT AVAILABLE. NO ADDITIONAL PT/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. BOTH POTENTIAL MANUFACTURING SITE NUMBERS ARE LISTED BELOW. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. 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 THE PT NEEDED SURGERY WHILE USING FMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255739 FLEXI-SEAL CONTROL FMS KIT US GASTROINTESTINAL TUBE & ACCESSORIES 78KNT KNT CONVATEC INC. 411107 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention