BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERISTEEN BAG/RECTAL CATHETERS

    MDR report key: 2200114 · Received August 10, 2011

    Report

    Report Number
    3006606901-2011-00024
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    May 30, 2011
    Report Date
    July 12, 2011
    Manufacturer
    COLOPLAST A/S
    Product Code
    KNT
    PMA / PMN Number
    K103254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT FROM (B)(6) REPORTED BY A NURSE CONCERNS A (B)(6) FEMALE WITH SEVERE CONSTIPATION AND FECAL INCONTINENCE THAT DEVELOPED BOWEL PERFORATION/PARARECTAL ABSCESS AFTER USE OF PERISTEEN ANAL IRRIGATION. ONE AND A HALF MONTH AFTER FIRST TIME TREATMENT WITH PERISTEEN ((B)(6) 2011) THE PATIENT BEGAN TO FEEL UNWELL AND HAD DIARRHEA. SHE STOPPED THE TREATMENT WITH PERISTEEN AND AFTER A FEW DAYS SHE CONTACTED HER DOCTOR WHO SUSPECTED A URINARY TRACT INFECTION AND INITIATED ANTIBIOTIC TREATMENT. THE FOLLOWING DAYS SHE DID NOT GET BETTER, FELT UNWELL AND THE DIARRHEA CONTINUED. SHE WAS ADMITTED TO THE HOSPITAL WITH A PARARECTAL ABSCESS AND HAD A COLOSTOMY. SHE IS HOME AND WELL NOW HOWEVER SHE STILL HAS A LEAKING LEFT SINUS TRACKING APPROXIMATELY 6-7CM (NOT INFECTED). ON (B)(6) 2011 THE PATIENT WAS TRAINED AND PERFORMED THE IRRIGATION UNDER SUPERVISION BY A SPECIALIST NURSE. SHE HAD TELEPHONE CONTACT WITH THE PATIENT TWO WEEKS LATER (B)(6) WERE THE PATIENT EXPERIENCED THAT THE CATHETER AND BALLOON EXPELLED AND ONE BALLOON BURST. AT THE NEXT CONTACT ON THE (B)(6) THE TREATMENT WERE WORKING WELL AND THE PATIENT DID NOT COME TO THE CLINIC AT A SCHEDULED APPOINTMENT IN (B)(6). PATIENT STARTED USING PERISTEEN DUE TO SEVERE CONSTIPATION AND INCONTINENCE. PRIOR TREATMENT WAS MANUAL EVACUATION. MEDICAL HISTORY INCLUDES SPINAL CORD INJURY AND DIVERTICULAR DISEASE THAT SOMETIMES GAVE HER PAIN. NO HISTORY OF PRIOR SURGERY, MEDICAL TREATMENT (STEROIDS), X-RAY IN THE PELVIC REGION ETC. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) FOR PERISTEEN, BOWEL PERFORATION IS A VERY RARE COMPLICATION. THE USER IS INSTRUCTED TO CONTACT A HEALTH CARE PROFESSIONAL IF HE/SHE DURING OR AFTER ANAL IRRIGATION EXPERIENCES SEVERE AND SUSTAINED ABDOMINAL PAIN OR BACK PAIN, ESPECIALLY IF THE PAIN IS COMBINED WITH FEVER AND/OR SEVERE ANAL BLEEDING. AS WITH OTHER INVASIVE PROCEDURES LIKE ENDOSCOPY IT IS NOT POSSIBLE TO ELIMINATE THE RISK OF BOWEL PERFORATION. ACCORDING TO THE LITERATURE AND POST-MARKETING EXPERIENCE RISK FACTORS INCLUDE UNDERLYING DISEASES AND TREATMENTS LEADING TO WEAKENING OR OBSTRUCTION OF THE BOWEL. THIS IS ADDRESSED IN THE IFU AND THE USER IS INSTRUCTED TO CONSULT AND GET THOROUGHLY INSTRUCTED BY A HEALTH CARE PROFESSIONAL BEFORE USING THE PRODUCT. IN THIS CASE A (B)(6) FEMALE WITH SPINAL CORD INJURY AND SEVERE CONSTIPATION/ INCONTINENCE THAT WAS WELL TRAINED IN THE USE OF PERISTEEN DEVELOPED A PARARECTAL ABSCESS AFTER ONE AND HALF MONTHS USE. A CONTRIBUTING FACTOR TO THE EVENT MAY HAVE BEEN DIVERTICULAR DISEASE THAT OCCASIONALLY GAVE SYMPTOMS. THERE IS NO INDICATION THAT THE INJURY IS CAUSED BY ANY MALFUNCTION, FAILURE OR DETERIORATION IN THE CHARACTERISTICS AND/OR PERFORMANCE OF THE PRODUCT. MEDICAL ASSESSMENT WAS PERFORMED BY COLOPLAST'S MEDICAL ADVISOR (B)(4).

    Description of Event or Problem · 1

    (B)(6). DATE OF EVENT: (B)(6) 2011. ACCORDING TO THE INFORMATION RECEIVED, A NURSE REPORTED A COLON PERFORATION. A (B)(6) FEMALE USING THE PERISTEEN ANAL IRRIGATION SYSTEM FELT UNWELL AND HAD DIARRHEA. SHE WAS ADMITTED TO THE HOSPITAL WITH A PARARECTAL ABCESS AND HAD A COLOSTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERISTEEN BAG/RECTAL CATHETERS RECTAL CATHETER KNT COLOPLAST A/S 2912201006

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R