BEUDAMED
    FDA Adverse Event Death Summary report: N

    SUR-FIT NATURA 2PC-STOMAHESIVE MOLDABLE WAFER

    MDR report key: 3312671 · Received August 22, 2013

    Report

    Report Number
    1049092-2013-00006
    Event Type
    Death
    Date Received
    August 22, 2013
    Date of Event
    July 21, 2013
    Report Date
    July 24, 2013
    Manufacturer
    CONVATEC INC
    Product Code
    EZQ
    PMA / PMN Number
    K800750
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SERIOUS ADVERSE EVENT (DEATH) INVOLVED A MALE PT (AGE AND MEDICAL HISTORY UNK) WHO WAS ON ADMISSION ON A RESPIRATORY WARD AND WAS USING THE MOLDABLE TECHNOLOGY TWO PIECE SYSTEM SKIN BARRIER SYSTEM OVER A COLOSTOMY STOMA. THE PT HAS HAD HIS COLOSTOMY FOR A COUPLE OF YRS, EXACT DATE NOT KNOWN. THE PT REPORTEDLY IRRIGATED HIS STOMA. IT WAS NOT KNOWN IF BOWEL SOUNDS WERE PRESENT OR STOOL NOTED WHILE THE APPLIANCE WAS IN PLACE OR PRIOR TO PLACEMENT ON (B)(6) 2013. APPROXIMATELY 2 DAYS AFTER THE MOLDABLE 2 PIECE APPLIANCE WAS PLACED, THE PT REPORTEDLY HAD BOWEL OBSTRUCTION, 'ASPIRATED' AND WENT INTO RESPIRATORY FAILURE AND WAS PLACED ON A VENTILATOR. HE HAD A TOTAL COLECTOMY PERFORMED DATE UNK AND EVENTUALLY EXPIRED FROM SEPTIC SHOCK OVER WEEKEND OF (B)(6). FURTHER PT AND EVENT DETAILS WILL BE REQUESTED FROM THE REPORTING FACILITY. ALSO A PROFESSIONAL ASSESSMENT OF THE CAUSE OF DEATH AND ITS RELATEDNESS TO THE USE OF THE DEVICE WILL BE REQUESTED. FROM A CLINICAL PERSPECTIVE, A CAUSAL RELATIONSHIP BETWEEN THE S4S/SUR-FIT NATURA 2 PC - 2 PC STOMAHESIVE (SH) MOLDABLE WAFER AND THIS EVENT IS UNK AT THIS TIME. REPORTED TO THE FDA ON (B)(4)2013.

    Description of Event or Problem · 1

    A NURSE REPORTED THAT ANOTHER NURSE MISTAKENLY PLACED ONE OF THE TWO PIECE APPLIANCE ON A PT WITHOUT REMOVING THE PLASTIC FILM ON THE BACK OF THE WAFER. THE WAFER WAS HELD ON ONLY BY THE TAPE BORDER AROUND THE SKIN BARRIER. THIS REMAINED IN PLACE FOR TWO DAYS, RESULTING IN A TOTAL BLOCKAGE OF THE BOWEL. THE PT'S ABDOMEN BECAME VERY DISTENDED AND FIRM, AND THE PT BECAME SEPTIC AND WAS LATER TRANSFERRED TO CRITICAL CARE. WHEN THE SURGEON WAS CONSULTED, HE ATTEMPTED TO DO A DIGITAL INSPECTION OF THE COLOSTOMY, AND FOUND THE FILM OF THE BARRIER OCCLUDED THE STOMA. WHEN THE FILM WAS REMOVED, THE STOMA EXPELLED A LARGE AMOUNT OF GAS AND STOOL. ACCORDING TO THE REPORTER, THE PT HAD TO BE TAKEN TO THE OPERATING ROOM FOR A TOTAL COLECTOMY SECONDARY TO C. DIFF COLITIS. HE PASSED AWAY WITHIN A FEW DAYS AS A RESULT OF SEPTIC SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408728 SUR-FIT NATURA 2PC-STOMAHESIVE MOLDABLE WAFER OSTOMY POUCH AND ACCESSORIES EZQ CONVATEC INC 411805 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O