BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEM/COM (DISTRIBUTED BY O/METER)

    MDR report key: 314928 · Received February 5, 2001

    Report

    Report Number
    MW1020994
    Event Type
    Injury
    Date Received
    February 5, 2001
    Date of Event
    January 28, 2001
    Report Date
    January 29, 2001
    Manufacturer
    TEM COM
    Product Code
    FLK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TEM-COM MERCURY THERMOMETER BROKEN OFF IN INFANTS RECTUM. THERMOMETER APPEARED NORMAL PRIOR TO INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4424 TEM/COM (DISTRIBUTED BY O/METER) MERCURY THERMOMETER FLK TEM COM NA *

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Required Intervention