BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXI-SEAL FMS FECAL MANAGEMENT SYSTEM KIT

    MDR report key: 3688205 · Received March 14, 2014

    Report

    Report Number
    2243969-2014-00062
    Event Type
    Death
    Date Received
    March 14, 2014
    Date of Event
    June 8, 2011
    Report Date
    June 8, 2011
    Manufacturer
    CONVATEC INC.
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS BEING REPORTED AS A DEATH; HOWEVER, WHILE FLEXISEAL WAS REPORTED IN THE ARTICLE TO HAVE BEEN IS USE, IT IS DEEMED NOT CAUSALLY RELATED TO THE DEATH OF THE PT. QUALITY EVALUATION PERFORMED ON (B)(4) 2011 BASED ON THE FOLLOWING REQUIREMENTS: A LOT NUMBER COULD NOT BE OBTAINED THEREFORE A REVIEW OF THE BATCH RECORD DATA COULD NOT BE PERFORMED WITHOUT A VALID LOT NUMBER. A REVIEW OF THE COMPLAINT LISTING FOR THE PREVIOUS 12 MONTHS FOR THE PRODUCT ICC CODES INDICATES THAT THERE WERE FIVE (5) CASES REGISTERED FOR THIS COMPLAINT ISSUE. NO EVENTS OR CAPAS RELATING TO THE COMPLAINT ISSUE WERE FOUND IN THE GLOBAL NON-CONFORMANCE REPORTING SYSTEM FOR THE PREVIOUS 12 MONTHS OF CASE CREATION. LASTLY, NO RETURNED PRODUCT WAS RECEIVED AT (B)(4) CONVATEC PLANT AT THE TIME OF THIS EVALUATION - COMPLAINT NOT CONFIRMED. 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. 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. REPORTED TO THE FDA ON MARCH 13, 2014. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S COMPLAINT HANDLING AND CAPA PROCEDURES. NOTE: THE ACTUAL DATE OF EVENT IS UNK, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE.

    Description of Event or Problem · 1

    BASED ON THE INFORMATION REFERENCED FROM THE (B)(6) 2011 ARTICLE PUBLISHED IN THE TURKISH JOURNAL OF TRAUMA AND EMERGENCY SURGERY, (B)(6) MALE ADMITTED WITH FLAME BURN. TBSA 70 PERCENT. EXPIRED ON POST-ADMISSION DAY 2 FROM MULTIPLE ORGAN FAILURE. NO ADDITIONAL DETAIL ABOUT THIS PT WS PROVIDED IN THE ARTICLE EXCEPT THE FOLLOWING: THE FLEXISEAL WAS IN USE DURING THE HOSPITALIZATION. FIFTEEN 15 (4.3) PERCENT OF A TOTAL OF 351 PTS (MEAN AGE 43 YEARS) ADMITTED TO THE BURN CENTER BETWEEN (B)(6) 2008 AND (B)(6) 2009 WITH PERINEAL (INCLUDING GLUTEUS AND UPPER THIGH) BURNS (MEAN TBSA PERCENT WAS 40.7+ 16.6). THE CATHETERS WERE PLACED INTRA-RECTALLY ON THE FIRST ADMISSION DAY IN ALL PTS BY A RESIDENT UNDER SEDATION OR GENERAL ANESTHESIA AFTER A DIGITAL RECTAL EXAMINATION TO DETECT ANY FECAL IMPACTION OR ANORECTAL ABNORMALITY. MINIMAL FECAL LEAKAGE WAS SEEN IN 6 (40 PERCENT) PTS. THE RETENTION BALLOON WAS INFLATED WITH 45ML WATER AND PLACED CAREFULLY INTO THE PELVIC FLOOR. ADDITIONALLY, CATHETERS WERE IRRIGATED 3 TIMES DAILY WITH 100CC WATER TO AVOID OBSTRUCTION OF THE CATHETER. THE CATHETER WAS REMOVED WHENEVER A SATISFACTORY WOUND OR GRAFT HEALING WAS CONFIRMED BY A BURN SURGEON. THE LENGTH OF THE CATHETERIZATION DID NOT EXCEED 29 DAYS BASED ON THE MANUFACTURER'S RECOMMENDATION (MEAN DURATION OF CATHETERIZATION WAS 22.5 DAYS. ARTICLE STATES THAT A DIGITAL RECTAL EXAMINATION WAS PERFORMED ON ALL PTS TO DETECT ANY MUCOSAL INJURY AFTER REMOVAL OF THE CATHETER WITH RESULTS OF EXCEPT FOR SUPERFICIAL MUCOSAL EROSION IN THE DISTAL RECTUM IN 2 PTS, NO COMPLICATIONS DUE TO THE DEVICE WAS OBSERVED. LASTLY, ARTICLE STATES THAT COLOSTOMY WAS REQUIRED IN 1 PT BECAUSE OF WOUND HEALING DELAY (EXCEEDING 29 DAYS). THE MEAN HOSPITALIZATION TIME WAS 46.7 +/-12.7 DAYS (RANGE: 26-64).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154070 FLEXI-SEAL FMS FECAL MANAGEMENT SYSTEM KIT GASTROINTESTINAL TUBE AND ACCESSORIES KNT CONVATEC INC. 411100 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Death| L| O| R