BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIE

    MDR report key: 2627631 · Received August 7, 2009

    Report

    Report Number
    2627631
    Event Type
    Injury
    Date Received
    August 7, 2009
    Date of Event
    July 14, 2009
    Report Date
    August 6, 2009
    Manufacturer
    PIE MEDICAL INTERNATIONAL
    Product Code
    KQT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CS COMPLETE QUADRAPLEGIA MALE PRESENTED WITH A RECTAL PERFORATION REQUIRING COLECTOMY. HE DID NOT HAVE ANY KNOWN COLON DISEASE PRIOR. HE USED A PIE (PULSED IRRIGATION EVACUATION) DEVICE EVERY OTHER DAY. THE EMESIS AND ABDOMINAL PAIN BEGAN MORE THAN 24 HOURS AFTER USING THE PE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIE STOOL EVACUATION KQT PIE MEDICAL INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| L| R