BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOMETER

    MDR report key: 21424 · Received March 28, 1995

    Report

    Report Number
    2435790-1995-00001
    Event Type
    Malfunction
    Date Received
    March 28, 1995
    Date of Event
    September 19, 1993
    Report Date
    March 28, 1995
    Manufacturer
    POND'S LIMITED
    Product Code
    FLK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MO, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER STATED SHE INSERTED THE THERMOMETER INTO HER 7-MONTH-OLD DAUGHTER'S RECTUM FOR APPROX 2 MINUTES. UPON REMOVAL, SHE NOTED THAT THE BULB HAS SHATTERED IN HER DAUGHTER'S RECTUM. SHE STATED THAT THE MERCURY AND GLASS WERE VISIBLE ON AN X-RAY AND THAT THE CHILD'S URINE WOULD BE TESTED FOR THE PRESENCE OF MERCURY. SHE STATED THE THERMOMETER HAD BEEN PURCHASED IN 2/93 AND HAD BEEN USED IN THE PAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOMETER THERMOMETER FLK POND'S LIMITED 00313 601604

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO