BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIFLO ENTERAL FEEDING TUBE

    MDR report key: 327960 · Received April 18, 2001

    Report

    Report Number
    1528738-2001-00021
    Event Type
    Injury
    Date Received
    April 18, 2001
    Date of Event
    December 7, 2000
    Report Date
    March 20, 2001
    Manufacturer
    ROSS PRODUCTS DIVISION/ABBOTT LABORATORIES
    Product Code
    BSS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER STATED THE PHYSICIAN MET RESISTANCE WHILE PLACING THE DEVICE. WHEN REMOVED, THE STYLET WAS PROTRUDING THROUGH THE TUBE WALL. PT SUFFERED A NOSEBLEED. ONE PT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17655 FLEXIFLO ENTERAL FEEDING TUBE 78 BSS TUBE, NASOGASTRIC BSS ROSS PRODUCTS DIVISION/ABBOTT LABORATORIES 473 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention