BEUDAMED
    FDA Adverse Event Other Summary report: N

    PIE BP

    MDR report key: 679857 · Received February 27, 2006

    Report

    Report Number
    1061032-2006-00001
    Event Type
    Other
    Date Received
    February 27, 2006
    Date of Event
    August 18, 2004
    Report Date
    February 24, 2006
    Manufacturer
    PIE MEDICAL INTL., INC.
    Product Code
    KQT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WENT AGAINST PRINTED CONTRAINDICATION INSTRUCTIONS FOR PRE-EXISTING PATIENTS CONDITIONS. THE PIE PROCEDURE SHOULD NOT BE USED WITH ANY PATIENT WITH A PRE-EXISTING CONDITION, I.E.. RECENT COLON SURGERY. THE AVOIDABLE RESULTS WERE A SMALL FISSURE, WAS CREATED IN RECTAL AREA WHERE THE SURGERY HAD BEEN PREVIOUSLY PERFORMED. PHYSICIAN HAS ADMITTED THAT IT WAS HIS MISTAKE TO USE THE PIE PROCEDURE WITH THIS PATIENT. THE PHYSICIAN HAS ALSO STATED THAT THE PIE SYSTEM DID NOT DYSFUNCTION DURING THIS REPORTED EVENT. THE PIE BP IS A FDA CLASS II PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIE BP BOWEL PROSTHETIC DEVICE KQT PIE MEDICAL INTL., INC. 2005 3

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization