BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT

    MDR report key: 4029634 · Received August 1, 2014

    Report

    Report Number
    1049092-2014-00380
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C.
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. 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. PLEASE NOTE: THERE ARE (B)(4) CASES ASSOCIATED WITH THIS PRODUCT; THEREFORE, A SEPARATE FDA FORM 3500A HAS BEEN GENERATED TO ADDRESS THE OTHER (B)(4) CASES. IN ADDITION, AS STATED ON THE COMPLAINT FORM PROVIDED, THE EVENTS OCCURRED FOUR TIMES BETWEEN (B)(6) 2014. 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 PATIENT DEVELOPED SACRAL ESCHAR ASSOCIATED WITH THE SKIN COMING IN CONTACT WITH STOOLS LEAKAGE RESULTING FROM WATER LEAKAGE WHEN INFLATING THE FLEXI-SEAL SIGNAL BALLOON. IT IS FURTHER REPORTED THAT THE EVENT OCCURRED BETWEEN FOUR HOURS AND THREE DAYS AND ALL DEVICES FIVE FLEXI-SEAL IN FIFTEEN DAYS WERE DISCONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449609 FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT FASTROINTESTINAL TUBE AND ACCESSORIES, 78 KNT KNT CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C. 418000 13FM0208

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention