BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULL METHOD ENTERAL FEEDING DEVICE

    MDR report key: 513284 · Received February 26, 2004

    Report

    Report Number
    6000048-2004-00008
    Event Type
    Injury
    Date Received
    February 26, 2004
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INFO FROM A POST MARKET STUDY REVEALED INFECTION AT THE PEJ SITE. THE PT WAS TREATED WITH GETIFLOXACIN, LORTAB, AND TEQUIN. THE PEJ REMAINED IN THE PT AND WAS REMOVED LATER FOR TUBE OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULL METHOD ENTERAL FEEDING DEVICE ENTERAL FEEDING DEVICE KNT BOSTON SCIENTIFIC CORP. NA 5089923

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention