BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAYER GLUCOLET - 2

    MDR report key: 275292 · Received April 27, 2000

    Report

    Report Number
    MW1018756
    Event Type
    Injury
    Date Received
    April 27, 2000
    Date of Event
    November 1, 1999
    Report Date
    April 27, 2000
    Manufacturer
    BAYER CORP.
    Product Code
    FMK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PREVIOUSLY THIS PRODUCT WAS EMBOSSED WITH "AMES" AND FACILITY HAD NO PROBLEMS WITH IT. CURRENT PRODUCT EMBOSSED "BAYER" AND THE PROTECTIVE COVER COMES OFF EASILY LEAVING THE USED LANCET IN THE DEVICE. WITH THIS NEW DESIGN/PRODUCT THE FACILITY HAS HAD 3 NEEDLE STICKS TO STAFF SINCE 11/99. PREVIOUS TO THIS THE FACILITY HAD NO REPORTED STICKS IN AT LEAST 3 YRS.

    Description of Event or Problem · 2

    PREVIOUSLY THIS PRODUCT WAS EMBOSSED WITH "AMES" AND FACILITY HAD NO PROBLEMS WITH IT. CURRENT PRODUCT EMBOSSED "BAYER" AND THE PROTECTIVE COVER COMES OFF EASILY LEAVING THE USED LANCET IN THE DEVICE. WITH THIS NEW DESIGN/PRODUCT THE FACILITY HAS HAD 3 NEEDLE STICKS TO STAFF SINCE 11/99. PREVIOUS TO THIS THE FACILITY HAD NO REPORTED STICKS IN AT LEAST 3 YEARS.

    Description of Event or Problem · 3

    PREVIOUSLY THIS PRODUCT WAS EMBOSSED WITH "AMES" AND FACILITY HAD NO PROBLEMS WITH IT. CURRENT PRODUCT EMBOSSED "BAYER" AND THE PROTECTIVE COVER COMES OFF EASILY LEAVING THE USED LANCET IN THE DEVICE. WITH THIS NEW DESIGN/PRODUCT THE FACILITY HAS HAD 3 NEEDLE STICKS TO STAFF SINCE 11/99. PREVIOUS TO THIS THE FACILITY HAD NO REPORTED STICKS IN AT LEAST 3 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAYER GLUCOLET - 2 LANCET FMK BAYER CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR
    2 30 YR
    3 UNKNOWN