BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERISTEEN ANAL IRRIGATION SYSTEM

    MDR report key: 3953936 · Received July 23, 2014

    Report

    Report Number
    3006606901-2014-00007
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 25, 2014
    Manufacturer
    COLOPLAST A/S
    Product Code
    KNT
    PMA / PMN Number
    K103254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE IFU, BOWEL PERFORATION IS AN EXTREMELY RARE, BUT SERIOUS AND POTENTIALLY LETHAL COMPLICATION TO ANAL IRRIGATION THAT WILL REQUIRE IMMEDIATE ADMISSION TO HOSPITAL, OFTEN REQUIRING SURGERY. THE USER SHOULD CONTACT DOCTOR IMMEDIATELY, IF THE USER DURING OR AFTER ANAL IRRIGATION EXPERIENCE E.G. SEVERE AND SUSTAINED ABDOMINAL PAIN OR BACK PAIN, ESPECIALLY IF THE PAIN IS COMBINED WITH FEVER AND/OR SEVERE ANAL BLEEDING. THE USER IS ALSO INSTRUCTED TO CONSULT AND GET THOROUGHLY INSTRUCTED BY A HEALTH CARE PROFESSIONAL BEFORE USING THE PRODUCT. FURTHERMORE, THE FIRST IRRIGATION SHOULD BE SUPERVISED BY A HEALTH CARE PROFESSIONAL AND IN CASE OF CONSTIPATION, AN INITIAL, THROUGH CLEAN-OUT OF THE BOWELS IS RECOMMENDED BEFORE STARTING UP THE IRRIGATION PROCEDURE. IN THIS CASE A (B)(6) YEAR OLD PARAPLEGIC PATIENT EXPERIENCED RECTAL PREFORMATION FOLLOWING TRANSANAL IRRIGATION BY A TRAINED NURSE ON THE REHABILITATION SERVICE. THE PATIENT WAS HOSPITALIZED WITH RECTAL PERFORATION AND FECAL PERITONITIS. SURGICAL INTERVENTION INCLUDED LAPAROTOMY AND COLOSTOMY.

    Description of Event or Problem · 1

    (B)(6). DATE OF EVENT...(B)(6) 2014. ACCORDING TO THE INFORMATION RECEIVED, A (B)(6) YEAR OLD PARAPELEGIC PATIENT EXPERIENCED PERFORATION OF THE COLON. PERFORATION OCCURRED AFTER A TRANSANAL IRRIGATION PERFORMED BY A NURSE ON THE REHABILITATION SERVICE. THE CATHETER WAS INSERTED FROM BEHIND WITH DIFFICULTIES. IRRIGATION WAS PERFORMED BY A TRAINED NURSE WHILE THE PATIENT WAS LYING IN BED. THE IRRIGATION PROCEDURE INVOLVED 2 PUMPS IN WHICH 500 MLS WATER WAS INFUSED. THE CATHETER WAS IMMEDIATELY WITHDRAWN; NO FECES AFTER IRRIGATION AND THE WATER WAS REPORTED AS RED (LOW ABUNDANCE). BLEEDING, FEVER, AND ABDOMINAL PAIN REPORTED AFTER 90 MIN. THE PERFORATION OCCURRED 15 CM ABOVE THE ANAL SPHINCTER WITH A WOUND SIZE OF 5 CM IN THE RECTO-SIGMOID AND EXTENDED TO THE UPPER RECTUM. THE PATIENT WAS HOSPITALIZED IN INTENSIVE CARE FOR A RECTAL PERFORATION AND FECAL PERITONITIS. SURGICAL INTERVENTION INCLUDED LAPAROTOMY WITH COLOSTOMY PERFORMED ON (B)(6) 2014. INTENSIVE CARE DISCHARGE OCCURRED BEGINNING OF (B)(6) FOLLOWING STABILIZATION OF THE INFECTIOUS CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431842 PERISTEEN ANAL IRRIGATION SYSTEM RECTAL CATHETER KNT COLOPLAST A/S 2912101001

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L