BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BACT/ ALERT PF BOTTLE

    MDR report key: 495526 · Received September 10, 2003

    Report

    Report Number
    1039284-2003-00007
    Event Type
    Injury
    Date Received
    September 10, 2003
    Date of Event
    May 5, 2003
    Report Date
    September 10, 2003
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    MDB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER WAS TRYING TO REMOVE A POSITIVE BACT/ALERT PF BOTTLE FROM THE BACT/ALERT 3D INSTRUMENT WHEN THE NECK OF THE BOTTLE BROKE OFF. THE CUSTOMER WAS TREATED IN THEIR E.R., NO STITCHES WERE REQUIRED BUT A TETANUS SHOT WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BACT/ ALERT PF BOTTLE MICROBIAL GROWTH MONITOR MDB BIOMERIEUX, INC. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention