BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXI-SEAL SIGNAL FMS

    MDR report key: 3204721 · Received June 28, 2013

    Report

    Report Number
    2243969-2013-00017
    Event Type
    Injury
    Date Received
    June 28, 2013
    Date of Event
    June 27, 2012
    Report Date
    June 27, 2012
    Manufacturer
    CONVATEC
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING RECEIPT OF AN FDA WARNING LETTER (13-NWJ-08), THIS CASE WAS RE-OPENED AND RE-EVALUATED BY THE PRODUCT SAFETY AND REPORTABILITY COMMITTEE. AS A RESULT, THE MEDICAL DETERMINATION IS BEING CHANGED TO SERIOUS. THE COMPLAINT NARRATIVE DESCRIBED A MALFUNCTION (LEAKAGE) THAT LED TO THE EXPOSURE OF A SKIN GRAFTING TO FECAL MATTER. THE COMPLAINANT MENTIONED THE POSSIBILITY OF A LIFE THREATENING INFECTION ARISING FROM THIS EXPOSURE BUT ALSO REPORTED THAT THE INFECTION WAS PREVENTED DUE TO A PROMPT INTERVENTION BY MEDICAL STAFF. THIS EVENT OCCURRED IN (B)(6) 2012, AT THE LAST COMMUNICATION IN (B)(6) 2012, THE PT'S SKIN GRAFT WOUND WAS REPORTED AS "IMPROVING." ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER FACILITY - THE FOLLOWING ARE THE RESPONSES TO QUESTIONS ASKED IN OUR STANDARD QUESTIONNAIRE: ON WHAT PART OF THE BODY WAS THE GRAFT WOUND LOCATED? THE GRAFT WOUND IS LOCATED ON THE BACK, ALL ALONG. WAS THE GRAFT WOUND COVERED OR OPEN: COVERED WITH NON-OCCLUSIVE DRESSING. DID FECAL MATTER ACTUALLY COME INTO CONTACT WITH THE WOUND? YES. IF YES, WAS THE WOUND INFECTED AS A RESULT? DUE TO OUR FAST RESPONSE OF IMMEDIATELY REPLACING THE SYSTEM (IN A FEW HOURS), WE HAVE MANAGED TO PREVENT CONTINUOUS EXPOSURE AND POSSIBLE COMPLICATIONS. IN THE CLINICIAN'S OPINION, WAS THERE A DELAY IN WOULD HEALING IN THIS CASE? DUE TO OUR FAST RESPONSE OF IMMEDIATELY REPLACING THE SYSTEM (IN A FEW HOURS), WE HAVE MANAGED TO PREVENT CONTINUOUS EXPOSURE AND POSSIBLE COMPLICATIONS. DID THE EVENT LEAD TO A PROLONGATION IN THE DURATION OF HOSPITALIZATION? WE HAVE NO DATA TO ANSWER THIS QUESTION. ALTHOUGH THE RISK OF WOUND CONTAMINATION BY FECAL MATTER IS GREATLY REDUCED WITH THE USE OF THE FMS DEVICE WHEN COMPARED TO OTHER METHODS. THE POSSIBILITY OF CONTAMINATION AND WOUND INFECTION CANNOT BE COMPLETELY RULED OUT. THE PRODUCT INSERT UNDER PRECAUTIONS AND OBSERVATIONS WARNS END USERS TO PROVIDE FOR SKIN CARE AND INTERVENTIONS AS SOME "LEAKAGE OF STOOL AROUND THE DEVICE" IS TO BE EXPECTED. IN THE HOSPITAL SETTINGS WHERE THESE DEVICES ARE USED, THE STANDARD CLINICAL PRACTICE IS TO COVER WOUNDS WITH APPROPRIATE BARRIER DRESSINGS TO FACILITATE HEALING AND TO FURTHER REDUCE THE RISK OF FECAL CONTAMINATION. ON THE BASIS OF THE RE-EVALUATION OF THIS CASE, FOLLOWING THE RECEIPT OF WARNING LETTER 13-NWJ-08, THIS CASE IS DEEMED TO BE A SERIOUS INJURY [AS THE POTENTIAL FOR SERIOUS INJURY CANNOT BE RULED OUT IF THE MALFUNCTION WERE TO RECUR]. AN INVESTIGATION WAS CONDUCTED AND NO FURTHER ACTION IS REQUIRED BASED ON THE INVESTIGATION RESULTS: A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO DISCREPANCIES IDENTIFIED. RETAIN SAMPLES WERE TESTED AND ALL MET SPECIFICATION. NO NONCONFORMANCE RELATED TO MANUFACTURING PROCESS WAS IDENTIFIED. REPORTED TO THE FDA ON (B)(4) 2013. THE ACTUAL DATE OF EVENT IS UNK, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE.

    Description of Event or Problem · 1

    COMPLAINT IDENTIFIED IN A WARNING LETTER RECEIVED FROM THE FDA (13-NWJ-08). COMPLAINT RECEIVED FROM (B)(4). PRODUCT DAMAGED - FMS PUNCTURE. PUNCTURE/TEAR/CUT/HOLE IN BALLOON. THE BALLOON CAME OUT, HALF INFLATED. THERE WAS A DRIP OF WATER FROM THE BALLOON. REPORT IS BEING SUBMITTED DUE TO INTERVENTION BY MEDICAL STAFF TO PREVENT SERIOUS INJURY CAUSED BY LEAKAGE OF FECAL MATTER ON RECENT SKIN GRAFT ON BACK OF PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295819 FLEXI-SEAL SIGNAL FMS FECAL MANAGEMENT SYSTEM KNT CONVATEC NA 11VM420900

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R