BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIGNICARE STOOL MANAGEMENT SYSTEM

    MDR report key: 2230705 · Received August 17, 2011

    Report

    Report Number
    1018233-2011-00197
    Event Type
    Injury
    Date Received
    August 17, 2011
    Report Date
    August 15, 2011
    Manufacturer
    C.R. BARD, INC.
    Product Code
    KNT
    PMA / PMN Number
    K073598
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED TO BARD FOR EVAL. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY. THE DIRECTIONS FOR USE STATES IN THE CONTRAINDICATION SECTION, IT STATES: "DO NOT USE ON PTS WITH ANY RECTAL OR ANAL INJURY, SEVERE RECTAL OR ANAL STRICTURE OR STENOSIS (OR ON ANY PT IF THE DISTAL RECTUM CANNOT ACCOMMODATE THE INFLATED CUFF), CONFIRMED RECTAL OR ANAL TUMOR, SEVERE HEMORRHOIDS, OR FECAL IMPACTION. NOT FOR USE ON PTS WITH SUSPECTED OR CONFIRMED RECTAL MUCOSA IMPAIRMENT, IC SEVERE PROCTITIS, ISCHEMIC PROCTITIS, MUCOSAL ULCERATIONS. NOT FOR USE ON PTS WITH INDWELLING RECTAL OR ANAL DEVICE (EG THERMOMETER) OR DELIVERY MECHANISM (EG SUPPOSITORIES) OR ENEMAS IN PLACE." THE USER FACILITY HAS DETERMINED THAT THE SYS ITSELF WAS MOST LIKELY NOT RESPONSIBLE FOR THE BLEEDING THAT OCCURRED. THEY STATED, "THE CONTINUED SUCCESS OF THE DIGNICARE SYS WITHOUT ANY FURTHER INCIDENCES OF RECTAL BLEEDING THROUGHOUT THE HOSP HAS LEAD US TO THIS CONCLUSION." (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO WEEKS AFTER PLACEMENT, THE PT BEGAN HAVING BRIGHT RED STOOLS. THE PT HAD A RECTAL EXAMINATION AND WAS TAKEN FOR A COLONOSCOPY WITH SURGICAL LIGATION OF THE RECTAL VESSEL. THERE WAS NO PREVIOUS HISTORY OF RECTAL SURGERY IN THE LAST YEAR. THE DEVICE HAS BEEN REMOVED FROM THE PT.

    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 69 YR Required Intervention