BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT

    MDR report key: 3954802 · Received July 18, 2014

    Report

    Report Number
    1049092-2014-00317
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 26, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. IT IS FURTHER REPORTED THAT THE RELATED INCIDENT WAS EXPLAINED IN A LETTER DELIVERED TO CONVATEC IN REGARDS TO THE LAST FIFTEEN (15) DAYS, SPECIFICALLY RELATED TO THE PHARMACEUTICAL CHEMIST AND NURSE LEAD IN CHARGE. LASTLY, REPORT STATES: "CONVERSELY SURGEONS WHO VALUE PATIENTS EXPRESSED THE NEED TO CONTINUE THE ISOLATION OF FECAL MATTER FROM THE WOUND, SO THEY DECIDED TO REINSERT ANOTHER FLEXI-SEAL FECAL MANAGEMENT SYSTEM KIT. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. 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. 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 IT WAS OBSERVED IN THE PREVIOUS WEEK (EXACT DATE UNKNOWN), THAT THE PATIENT EXPELLED NECROTIC RECTAL MUCOSA WITH NO SIGNS OF BLEEDING OR OTHER FINDINGS WHICH WAS DOCUMENTED AND REPORTED TO THE SURGEON ON DUTY, ASSOCIATED WITH HAVING THE FLEXI-SEAL FECAL MANAGEMENT SYSTEM DEVICE IN PLACE. IT IS FURTHER REPORTED THAT DURING A VISIT ON (B)(6) 2014 TO ASSESS THE TRACKING DEVICE WHICH WAS NOT REPORTED AT THE TIME, EVIDENCE SHOWED THAT THE DEVICE WAS IN THE PATIENT FOR THIRTY FIVE (35) DAYS AND HAD NOT BEEN WITHDRAWN DUE TO THE NEED TO CONTINUE WITH THE DEVICE, "AND TO ALERT THE FECAL MANAGEMENT SYSTEM INVIMA HAD NOT MAKE ANOTHER TO CREATE CHANGE". LASTLY, REPORTS STATES THAT ON (B)(6) 2014, COMPLAINANT PERFORMED A NEW TRACK WHICH PROVIDED EVIDENCE OF THE INCIDENT WHICH WAS THEN COMMUNICATED TO THE SURGEON ON DUTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422154 FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT GASTROINTESTINAL TUBE & ACCESSORIES 78 KNT KNT CONVATEC INC. 411100 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention