BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXI-SEAL FMS FECAL MANAGEMENT SYSTEM KIT

    MDR report key: 3688180 · Received March 14, 2014

    Report

    Report Number
    2243969-2014-00061
    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 INFO, THIS EVENT IS BEING REPORTED AS A DEATH; HOWEVER, AS PER THE CHIEF SAFETY MEDICAL OFFICER, THE PRODUCT IS BEING DEEMED NOT RELATED TO THE DEATH OF THE PT. QUALITY EVAL 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 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 EVAL. COMPLAINT NOT CONFIRMED. NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVAL IS NOT EXPECTED. SHOULD ADDITIONAL INFO BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE LOT NUMBER WAS NOT PROVIDED. THEREFORE, WE ARE UNABLE TO DETERMINE THE SPECIFIC MFG SITE. BOTH POTENTIAL MFG SITE NUMBERS ARE LISTED BELOW. A RETURN SAMPLE FOR EVAL IS NOT EXPECTED. 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 INFO REFERENCED FROM THE MARCH 2011 ARTICLE PUBLISHED IN THE TURKISH JOURNAL OF TRAUMA AND EMERGENCY SURGERY, (B)(6) OLD MALE ADMITTED WITH ELECTRICAL BURNS TBSA 60%. EXPIRED ON POST-ADMISSION DAY 14 FROM SEPTICEMIA. NO ADD'L DETAIL ABOUT THIS PT WAS PROVIDED IN THE ARTICLE EXCEPT THE FOLLOWING: THE FLEXISEAL WAS IN USE DURING THE HOSPITALIZATION. FIFTEEN (4.3)% OF A TOTAL OF 351 PTS (MEAN AGE 43 YEARS) ADMITTED TO THE BURN CENTER BETWEEN AUGUST 2008 AND AUGUST 2009 WITH PERINEAL (INCLUDING GLUTEUS AND UPPER THIGH) BURNS (MEAN TBSA% 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%) 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 MFR'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 PT, 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
    154437 FLEXI-SEAL FMS FECAL MANAGEMENT SYSTEM KIT GASTROINTESTINAL TUBE & ACCESSORIES, 78KNT KNT CONVATEC INC. 411100 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Death| L| O| R