BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERISTEEN BAG/RECTAL CATHETERS

    MDR report key: 2223589 · Received August 25, 2011

    Report

    Report Number
    3006606901-2011-00027
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    May 27, 2011
    Report Date
    July 27, 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

    COLOPLAST MEDICAL ADVISOR HAS INTERVIEWED THE NURSE WHO REPORTED THE INCIDENT. ACCORDING TO THE NURSE A CONTRIBUTING FACTOR TO THE EVENT WAS THAT THE TRAINING OF THE PATIENT WAS COMPLICATED BY LANGUAGE DIFFICULTIES. PRIOR TO THE INCIDENT THE PATIENT HAD EXPERIENCED BALLOON BURST AND THE SURGEON FOUND BALLOON REMNANTS IN THE BOWEL. THE BALLOON BURST IS NOT CONSIDERED TO BE RELATED TO BOWEL PERFORATION. 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)(4) ACCORDING TO THE INFORMATION RECEIVED, A NURSE REPORTED A COLON PERFORATION. A YOUNG MALE WITH SPINAL CORD INJURY EXPERIENCED RECTAL PERFORATION AFTER 6 WEEKS USE OF PERISTEEN. THE PATIENT SUFFERED A HIGH TEMPERATURE AND RIGORS SOON AFTER COMPLETION OF THE IRRIGATION.

    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 Hospitalization| R