FDA.reportPublic FDA data

MAUDE MDR 220915

MDR report key
220915
Report number
MW1016205
Event key
0
Event type
3
Date of event
1999-04-26
Date received
1999-04-28
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1REIORAL THERMOMETERHART HEALTH AND SAFETYFLKFIRST AID THERMOMETERD050 407 20 99096*NY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11999-04-2801. O

Event Narratives#

D

Patient 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.