BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXI-SEAL SIGNAL FMS

    MDR report key: 2553133 · Received April 25, 2012

    Report

    Report Number
    2243969-2012-00029
    Event Type
    Injury
    Date Received
    April 25, 2012
    Date of Event
    March 23, 2012
    Report Date
    March 27, 2012
    Manufacturer
    CONVATEC, A DIVISION OF E.R. SQUIBB & SONS, L.L.C.
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REPLACED INITIALLY WHEN THE FIRST INCIDENCE SETTLED. THE PT HAD A HISTORY OF RECTAL POLYPS PRIOR TO DEVICE USE. PT HAD A COLONOSCOPY AND ANOSCOPY AFTERWARDS, BLOOD TRANSFUSION WAS NOT REQUIRED. HOSPITAL STAY WAS PROLONGED BY 1-2 DAYS. FROM A CLINICAL PERSPECTIVE, A CAUSAL RELATIONSHIP BETWEEN THE FLEXI-SEAL SIGNAL FMS AND THIS EVENT IS DEEMED POSSIBLE BECAUSE OF THE RELATIONSHIP BETWEEN THE TIMING OF THE EVENT AND THE USE OF THE PRODUCT. (B)(4).

    Description of Event or Problem · 1

    COMPLAINT RECEIVED AS FOLLOWS: RN CWCN REPORTED THAT THERE WAS BRIGHT RED BLOOD PRESENT IN THE FMS TUBING ON (B)(6), 2012. THE PRODUCT WAS DISCONTINUED; THE RECTUM WAS PACKED; THE BLEEDING STOPPED; A SIGMOIDOSCOPY WAS PERFORMED; AN ULCER WAS IDENTIFIED; AND THE PT STATUS IS PRESENTLY STABLE. RECTAL BLEEDING IS DEEMED SERIOUS AS THE PT REQUIRED MEDICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OF BODILY STRUCTURE OR FUNCTION. FURTHER INFO WAS RECEIVED. THE PT WAS SAID TO HAVE BEEN BEDRIDDEN. AN ESTIMATED 400CC OF BLEEDING WAS REPORTED AND BLEEDING WAS CONTROLLED BY ¿PACKING¿ THE RECTUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXI-SEAL SIGNAL FMS FECAL MANAGEMENT SYSTEM KNT CONVATEC, A DIVISION OF E.R. SQUIBB & SONS, L.L.C. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R