BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERISTEEN ANAL IRRIGATION SYSTEM

    MDR report key: 2880227 · Received December 19, 2012

    Report

    Report Number
    3006606901-2012-00019
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    November 11, 2012
    Report Date
    November 19, 2012
    Manufacturer
    COLOPLAST A/S
    Product Code
    KNT
    PMA / PMN Number
    K103254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VERY LIMITED INFORMATION WAS PROVIDED TO COLOPLAST REGARDING THIS COMPLAINT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    VERY LIMITED INFORMATION WAS PROVIDED TO COLOPLAST REGARDING THIS COMPLAINT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED. FOLLOW UP 1 A MEDICAL EVALUATION WAS PERFORMED BY COLOPLAST. 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 THE END-USER HAS EXPERIENCED BOWEL PERFORATION AND WAS HOSPITALIZED. THE END-USER FELT SUDDENLY PAIN DURING INSERTION OF THE CATHETER. HER MEDICAL HISTORY INCLUDE SURGERY FOR RECTUM CARCINOMA (B)(6). BASED ON THE AVAILABLE INFORMATION NO FURTHER CONCLUSIONS ARE POSSIBLE.

    Description of Event or Problem · 1

    (B)(4).ACCORDING TO THE INFORMATION RECEIVED, A DISTRIBUTOR REPORTED AN INCIDENT REGARDING A COLON PERFORATION. NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    PATIENT IDENTIFIER: (B)(6). DATE OF EVENT, BEST ESTIMATE: (B)(6) 2012. ACCORDING TO THE INFORMATION RECEIVED, A DISTRIBUTOR REPORTED AN INCIDENT REGARDING A COLON PERFORATION. NO OTHER INFORMATION WAS PROVIDED. FOLLOW UP 1...ADDITIONAL INFORMATION PROVIDED. ON THE (B)(6) 2012 AROUND 10 AM AT HOME DURING THE INSERTION OF THE RECTAL CATHETER THE END-USER FELT A SUDDEN UNKNOWN PAIN. SHE IMMEDIATELY REMOVED THE CATHETER AND FOUND CONSIDERABLE AMOUNTS OF BLOOD ON THE CATHETER AND TUBE. AFTERWARDS THE END-USER EXPERIENCED SEVERE ABDOMINAL PAIN AND WAS HOSPITALIZED IMMEDIATELY AT CLINIC (B)(6). THE EXAMINATION REVEALED THAT THE END-USER HAS PERFORATION OF THE BOWEL. AT THE (B)(6) 2013 THE END-USER HAS BEEN HOSPITALIZED FOR 7 WEEKS. SHE HAS UNDERGONE ONE SURGICAL INTERVENTION AND ANOTHER SURGICAL INTERVENTION WITH BOWEL RELOCATION IN THE SPRING OF 2013 HAS BEEN DISCUSSED. THE INDICATION FOR IRRIGATION WAS CONTINUOUS DIARRHEA AND FECAL INCONTINENCE. THE END-USER WAS TRAINED BY (B)(4). THE END-USER STARTED IRRIGATION AT THE (B)(6) 2012 AND IRRIGATED HERSELF EVERY 2-3 DAY, HENCE THE PERFORATION OCCURRED AFTER AROUND 4 WEEKS. THE USUAL IRRIGATION WAS PERFORMED WITH TWO PUMPS FOR BALLOON INFLATION AND INFUSION OF 500-600 ML OF WATER. MEDICAL HISTORY INCLUDES SURGERY FOR RECTUM CARCINOMA (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERISTEEN ANAL IRRIGATION SYSTEM RECTAL CATHETER KNT COLOPLAST A/S 2912301004 3413551

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other