BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXI-SEAL FMS

    MDR report key: 3022799 · Received March 22, 2013

    Report

    Report Number
    2243969-2013-00012
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    January 21, 2013
    Report Date
    February 27, 2013
    Manufacturer
    CONVATEC
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT INVOLVED IN THIS CASE IS (B)(6) FEMALE. (B)(6) WHO HAD RECTAL BLEEDING POSSIBLY RELATED TO THE USE OF THE FLEXI-SEAL FMS DEVICE. PATIENT WAS ON ADMISSION IN THE HOSPITAL FOR CONFUSION AND HIGH BLOOD PRESSURE; SHE ALSO HAD SACRAL ULCERS AND HAD FREQUENT LOOSE STOOLS. HER CO MORBIDITIES INCLUDES; RENAL FAILURE (ON HEMODIALYSIS), MULTIPLE MYELOMA, VASCULITIS, NON INSULIN DEPENDENT DIABETES MELLITUS AND SEPTIC SHOCK. THE PATIENT WAS ON HEPARIN (ANTICOAGULANT) FROM (B)(6) 2013. THE DEVICE WAS INSERTED (B)(6) 2012 AND REMOVED 21 DAYS LATER ON (B)(6) 2013 WHEN BLEEDING DESCRIBED AS 'MODERATE WITH CLOTS' WAS NOTICED. SHE UNDERWENT A COLONOSCOPY ON (B)(6) 2013 AND MULTIPLE RECTAL ULCERS WERE FOUND AT LEAST 6 IN THE 'DISTANT' RECTUM SAID TO BE LIKELY SECONDARY TO RECTAL TRAUMA. ACCORDING TO THE COLONOSCOPY REPORT, THE MOST LIKELY CAUSE OF THE RECTAL BLEEDING WAS DIVERTICULOSIS. SHE WAS TRANSFUSED WITH AN UNSTATED NUMBER OF UNITS OF BLOOD PRODUCTS. THE PATIENT RECOVERED FROM THE EVENT BUT IT HAD PROLONGED HER HOSPITAL STAY. SHE HAS SINCE BEEN TRANSFERRED TO A LONG TERM FACILITY. BASED ON AVAILABLE INFORMATION, MEDICAL DETERMINATION IS THAT THIS AE 'RECTAL BLEEDING' IS SERIOUS AS THE PATIENT'S HOSPITAL STAY WAS PROLONGED AND THE EVENT REQUIRED BOTH SURGICAL AND MEDICAL DIAGNOSTIC AND THERAPEUTIC INTERVENTIONS TO CORRECT. THE USE OF THE FLEXI-SEAL FMS DEVICE IS ALSO DEEMED POSSIBLY RELATED TO THE OCCURRENCE OF THE EVENT BECAUSE IT WAS IN USE AT THE TIME. REPORTED TO THE FDA ON (B)(4) 2013.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED AS FOLLOWS: "FMS INSERTED (B)(6) 2012 AND REMOVED (B)(6) ON (B)(6) 2013 DUE TO RECTAL BLEEDING. INSERTED USING 45ML FLUID. WAS DEFLATED AND REINFLATED WITH 45ML FLUID (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120348 FLEXI-SEAL FMS FECAL MANAGEMENT SYSTEM KNT CONVATEC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R