BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIGNICARE STOOL MANAGEMENT SYSTEM

    MDR report key: 1667407 · Received April 23, 2010

    Report

    Report Number
    1018233-2010-00035
    Event Type
    Death
    Date Received
    April 23, 2010
    Date of Event
    March 6, 2010
    Report Date
    April 23, 2010
    Manufacturer
    C.R. BARD, INC.
    Product Code
    KNT
    PMA / PMN Number
    K073598
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    IT SHOULD BE NOTED THAT THE RISK MANAGER OF THE USER FACILITY REPORTED THAT SHE "DID NOT FEEL THAT THE DEVICE PLACEMENT AND GI BLEED WERE RELATED AS THE PRODUCT BALLOON WOULD NOT BE THAT FAR UP IN THE PATIENT'S RECTUM." A MEDICAL ASSESSMENT BY DR (B) (6) IS AS FOLLOWS: "IT APPEARS THAT THE REPORTED BLEEDING WAS NOT NOTED DURING THE USE OF, NOR UPON REMOVAL OF THE DIGNICARE DEVICE. IN ADDITION, THE ANGIOGRAPHIC STUDIES PERFORMED IDENTIFIED ANGIODYSPLASIA THROUGHOUT THE RECTOSIGMOID COLON, DESCENDING COLON AND CECUM WITH ACTIVE BLEEDING. IT IS VERY UNLIKELY THAT THE DIGNICARE, GIVEN THE ABSENCE OF BLEEDING DURING ITS USE AS WELL AS ITS LOCATION IN THE DISTAL RECTUM WOULD CAUSE LESIONS OR BLEEDING IN THE NOTED, MORE PROXIMAL, AFFECTED AREAS. THEREFORE, IT IS REASONABLE TO SUGGEST, BASED ON THE INFORMATION PROVIDED, THAT THE DIGNICARE DEVICE WAS NOT A CONTRIBUTOR TO THE MORBIDITY, AND EVENTUAL MORTALITY OF THIS PATIENT. FURTHERMORE, IT APPEARS THAT THIS PATIENT'S BLEEDING AROSE AS A COMPLICATION ASSOCIATED WITH THE ANGIODYSPLASIA." (B) (4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LONG TERM ACUTE CARE PATIENT WHO HAD BEEN PREVIOUSLY ADMITTED FOR SPINAL SURGERY BECAME UNSTABLE AND RETURNED TO THE HOSPITAL. FOLLOWING HIS RETURN, A DEVICE WAS PLACED AND WAS IN-SITU FOR 17 DAYS. THE PATIENT EVENTUALLY DIED FROM A LOWER GI BLEED. A POST MORTEM ENDOSCOPY WAS PERFORMED BY A GI PHYSICIAN INDICATING A RING OF ULCERS IN THE PATIENT'S RECTUM EXACTLY 5CM INTO THE RECTUM. ADDITIONAL INFORMATION WAS RECEIVED FROM THE HOSPITAL ON 4/12/2010 STATING THAT "A DEVICE WAS PLACED AND REMAINED IN-SITU FOR APPROXIMATELY 17 DAYS AND WAS REMOVED BEFORE (B) (6). NO BLEEDING WAS NOTED WHILE THE DEVICE WAS IN PLACE OR FOLLOWING REMOVAL. AFTER (B) (6), THE PATIENT WAS TRANSFERRED ELSEWHERE BUT RETURNED TO THE HOSPITAL ON (B) (6). A DEVICE WAS NOT PLACED UPON THE PATIENT'S RETURN TO THE HOSPITAL. ON (B) (6), AN ANGIOGRAPHY WAS PERFORMED AND ANGIODYSPLASIA WAS INDICATED THROUGHOUT THE RECTOSIGMOID COLON, DESCENDING COLON, AND CECUM. AN ACTIVE HEMORRHAGE WAS IDENTIFIED IN THE RECTUM. THE PATIENT DIED ON (B) (6) FROM A LOWER GI BLEED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIGNICARE STOOL MANAGEMENT SYSTEM KNT C.R. BARD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death