BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS

    MDR report key: 384295 · Received March 22, 2002

    Report

    Report Number
    384295
    Event Type
    Other
    Date Received
    March 22, 2002
    Date of Event
    February 26, 2002
    Report Date
    March 21, 2002
    Manufacturer
    OLYMPUS AMERICA, INC
    Product Code
    FDF
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT COLONOSCOPY IN 2002. ON THE FOLLOWING MONTH, FACILITY WAS NOTIFIED THAT PT DEVELOPED A BOWEL PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS PCF - 140L PEDIATRIC COLONOSCOPE FDF OLYMPUS AMERICA, INC PCF - 140L *

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Other