BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOMETER W/ PENCIL CASE, REC

    MDR report key: 276776 · Received May 5, 2000

    Report

    Report Number
    1417592-2000-00014
    Event Type
    Malfunction
    Date Received
    May 5, 2000
    Date of Event
    April 19, 2000
    Report Date
    May 4, 2000
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    FLK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY THE TIP OF THE RECTAL THERMOMETER CAME OFF WHEN BEING USED ON AN INFANT. X-RAYS WERE TAKEN AND WERE NEGATIVE FOR EITHER GLASS OR METAL. THE PT WAS MONITORED FOR 24 HOURS AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOMETER W/ PENCIL CASE, REC * FLK MEDLINE INDUSTRIES, INC. MDS70365 906M1303/907M1303

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention