BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT

    MDR report key: 3883638 · Received June 9, 2014

    Report

    Report Number
    1049092-2014-00172
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    April 24, 2014
    Report Date
    May 12, 2014
    Manufacturer
    CONVATEC INC
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON 08/11/2015. THIRD PARTY MFR REVIEWED THE ROUTERS USED TO MANUFACTURE LOT #13VM524362 AND NO DEVIATIONS OR DISCREPANCIES WERE NOTED. IT WAS DETERMINED THE LOT WAS MANUFACTURED WITHOUT INCIDENT. THE RETAINED SAMPLES FOR THIS LOT WERE INSPECTED AND WERE FOUND TO BE FUNCTIONAL AND NON-DEFECTIVE. NO PREVIOUS INVESTIGATIONS ARE AVAILABLE. AFTER A THOROUGH BATCH REVIEW NO DISCREPANCIES OR NON-CONFORMANCES WERE DISCOVERED. THERE IS NOT ENOUGH INFORMATION TO CONCLUDE THE PRODUCT DID NOT MEET SPECIFICATION AND PERFORM AS INTENDED. PRODUCT MONITORING REVIEWS WILL MONITOR FOR PRODUCT TRENDS IF THIS ISSUE WERE TO REOCCUR. NO FURTHER ACTIONS ARE REQUIRED AND THE COMPLAINT WILL BE CLOSED. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON 08/12/2015.

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. NO ADDITIONAL PT/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. 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 WAS FOUND TO HAVE NECROTIC AND BLEEDING RECTAL ULCERS LIKELY FROM PRESSURE OF FLEXI-SEAL BALLOON IN RECTUM. THE FLEXISEAL WAS IN PLACE FOR TWO WEEKS WHEN THE PT EXPERIENCED BRIGHT RED BLEEDING AND CLOTS, AND BLOOD PRESSURE DROPPED AND PT REQUIRED TWO (2) UNITS OF PACKED RED BLOOD CELLS, NS FLUID BOLUS. UPPER GI SCOPE PERFORMED IN AM AND WAS NEGATIVE. LASTLY, PT WAS GIVEN BOWEL PREP EVERY FOUR HOURS, AND HEMOGLOBIN AND HEMATOCRIT, AND A COLONOSCOPY WAS PERFORMED THAT EVENING. IT IS REPORTED THAT PRODUCT WAS IN USE FOR TWELVE (12) TO FOURTEEN (14) DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334092 FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT GASTROINTESTINAL TUBE AND ACCESSORIES , 78 KNT KNT CONVATEC INC 418000 13VM524362

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention