BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS

    MDR report key: 1060264 · Received June 3, 2008

    Report

    Report Number
    8010047-2008-00098
    Event Type
    Injury
    Date Received
    June 3, 2008
    Date of Event
    February 4, 2008
    Report Date
    May 5, 2008
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA PEDIATRIC COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORPORATION PCF-160AL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Hospitalization| R