BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXI-SEAL FMS ADVANCED ODOR CONTROL

    MDR report key: 2221338 · Received August 17, 2011

    Report

    Report Number
    2243969-2011-00023
    Event Type
    Death
    Date Received
    August 17, 2011
    Date of Event
    July 16, 2011
    Report Date
    July 19, 2011
    Manufacturer
    CONVATEC
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT IS DEEMED SERIOUS AS IT INVOLVED EVENTUAL ATTEMPT AT SURGICAL INTERVENTION AND LATER, DEATH. FROM A CLINICAL PERSPECTIVE, A CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THIS EVENT IS DEEMED POSSIBLE. REPORTED TO THE FDA ON (B)(4), 2011.

    Description of Event or Problem · 1

    REPORTED BY THE COMPLAINANT AS FOLLOWS... END USER IS A (B)(6). HE WAS ADMITTED TO ICU WITH DX PANCREATITIS AND CHOLECYSTITIS PLUS COMORBIDITIES. FMS INSERTED ON (B)(6)-2011 FOR DIARRHEA. STOOL POSITIVE FOR LACTOFERRIN (B)(6)-2011. THE WOUND OSTOMY NURSE DID NOT KNOW IF THE CRITERIA FOR WHO IS A CANDIDATE TO USE THE FMS WAS FOLLOWED IE RECTAL ASSESSMENT, CONTRAINDICATIONS. SHE ALSO DID NOT KNOW HOW MUCH FLUID WAS INSTILLED IN THE BALLOON. FMS REMOVED ON (B)(6)-2011. AT THAT TIME, AN ULCER WAS NOTED TO RECTAL AREA MEASURING 1 AND ONE HALF CM INCLUDING ONE CM EXTENDING OUTSIDE THE BODY AND ONE HALF A CM INSIDE THE BODY. FULL THICKNESS WITH RED TISSUE. UNABLE TO ASSESS DRAINAGE DUE TO CONTINUED DIARRHEA. THE WOUND OSTOMY NURSE STATED THAT THE PT HAD SEVERAL OPENINGS IN THE BOWEL WHICH SHE FELT WERE NOT RELATED TO FMS AND THAT THE PT EXPIRED WHICH SHE ALSO FELT WAS NOT RELATED TO FMS. SURGEON WAS UNABLE TO MOBILIZE THE BOWEL TO PERFORM COLOSTOMY DUE TO THIN TISSUE AND MANY ADHESIONS NOT RELATED TO FMS. RECEIVED HEPARIN AND VERSED THERAPY. WT 169 TO 181 LBS., HT 5 FT 4 INCH. PT EXPIRED ON (B)(6)-2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXI-SEAL FMS ADVANCED ODOR CONTROL FECAL MANAGEMENT SYSTEM KNT CONVATEC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death| R