BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIGNICARE STOOL MANAGEMENT SYSTEM

    MDR report key: 1971477 · Received January 21, 2011

    Report

    Report Number
    1018233-2011-00014
    Event Type
    Injury
    Date Received
    January 21, 2011
    Report Date
    December 22, 2010
    Manufacturer
    C.R. BARD, INC.
    Product Code
    KNT
    PMA / PMN Number
    K073598
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. THE DIRECTIONS FOR USE STATES IN REMOVAL OF DEVICE SECTION: "TO REMOVE THE CATHETER FROM THE RECTUM, THE RETENTION CUFF MUST BE DEFLATED." IT IS NOT KNOWN IF THE CUFF WAS COMPLETELY DEFLATED BEFORE DISCONTINUATION OF THE DEVICE. THE DIRECTIONS FOR USE ALSO STATES IN THE WARNING SECTION: "DO NOT OVER INFLATE RETENTION CUFF. RECTAL BLEEDING SHOULD BE INVESTIGATED TO ENSURE NO EVIDENCE OF PRESSURE NECROSIS FROM THE DEVICE. DISCONTINUATION OF USE OF THE DEVICE IS RECOMMENDED IF EVIDENT." IN THE CONTRAINDICATION SECTION, IT STATES: "DO NOT USE ON PATIENTS WITH ANY RECTAL OR ANAL INJURY, SEVERE RECTAL OR ANAL STRICTURE OR STENOSIS (OR ON ANY PATIENT IF THE DISTAL RECTUM CANNOT ACCOMMODATE THE INFLATED CUFF), CONFIRMED RECTAL OR ANAL TUMOR, SEVERE HEMORRHOIDS, OR FECAL IMPACTION. NOT FOR USE ON PATIENTS WITH SUSPECTED OR CONFIRMED RECTAL MUCOSA IMPAIRMENT, I.E. SEVERE PROCTITIS, ISCHEMIC PROCTITIS, MUCOSAL ULCERATIONS. NOT FOR USE ON PATIENTS WITH INDWELLING RECTAL OR ANAL DEVICE (E.G. THERMOMETER) OR DELIVERY MECHANISM (E.G. SUPPOSITORIES) OR ENEMAS IN PLACE." IT SHOULD BE NOTED THAT BARD REPRESENTATIVES HAVE VISITED THIS FACILITY TO MEET WITH MATERIALS MANAGER, (B)(6), TO DISCUSS THIS INCIDENT. RETRAINING WAS OFFERED BUT DECLINED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUFF ON A DEVICE WAS INFLATED WITH 80MLS OF WATER CAUSING A RECTAL BLEED. THE PATIENT REQUIRED A CAUTERIZATION AND BLOOD TRANSFUSIONS. NO ADDITIONAL INFORMATION COULD BE OBTAINED.

    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 UNK Required Intervention