BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REI

    MDR report key: 220915 · Received April 28, 1999

    Report

    Report Number
    MW1016205
    Event Type
    Malfunction
    Date Received
    April 28, 1999
    Date of Event
    April 26, 1999
    Report Date
    April 28, 1999
    Manufacturer
    HART HEALTH AND SAFETY
    Product Code
    FLK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR IS THE PT. HE BOUGHT THE DEVICE, AND PRIOR TO USE HE WASHED IT IN WARM WATER. AS HE WAS WASHING IT, HE EXPECTED TO SEE THE MERCURY RISE, BUT IT DID NOT. HE MADE THE WATER HOT, AND IT STILL DID NOT RISE. HE THEN PLACED IT IN HIS HAND WITH A FIRM, BUT NOT TIGHT GRIP. WITHIN 15 SECONDS, THE BULB TIP BROKE OFF AND THE MERCURY SPILLED TO THE FLOOR. RPTR DID NOT HAVE DIRECT CONTACT WITH THE MERCURY. WHILE ANALYZING THE GLASS, THE RPTR COULD SEE WHERE THE PASSAGE WAY FOR THE MERCURY WAS OCCLUDED, PREVENTING IT TO RISE. RPTR IS CONCERNED OVER WHAT COULD HAVE HAPPENED IF THE DEVICE WAS IN SOMEONE'S MOUTH AT THAT TIME. RPTR DID NOT SUSTAIN ANY INJURY, AND HAS RETAINED THE GLASS PORTION OF THE THERMOMETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REI ORAL THERMOMETER FLK HART HEALTH AND SAFETY FIRST AID THERMOMETER *

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other