FDA.reportPublic FDA data

MAUDE MDR 8417166

MDR report key
8417166
Report number
1314800-2019-00015
Event key
0
Event type
3
Date of event
2019-02-24
Date received
2019-03-13
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
SONJA WILKINSON
Address
400 DONALD LYNCH BOULEVARD SUITE 300 MARLBOROUGH 01752 US
Phone
508-508-5084
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VICKSDIGITAL THERMOMETERKAZ USA, INC., A HELEN OF TROY COMPANYFLLV912USUNKNOWNR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-03-1301. H; 2. L; 3. O

Event Narratives#

N

Patient 1

KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING, BUT IT HAS NOT YET BEEN RECEIVED.

D

Patient 1

A CONSUMER REPORTED THAT SHE LEFT HER CHILD UNATTENDED, TO MAKE BREAKFAST FOR 30 MINUTES, DURING WHICH TIME THE CHILD WAS LEFT TO PLAY WITH THE THERMOMETER. ACCORDING TO THE CONSUMER, THE CHILD CHEWED ON THE COVER OF THE THERMOMETER "LIKE A LOLLIPOP", AND SOMEHOW OPENED THE COVER OF THE UNIT. IN THE PROCESS, THE CHILD REMOVED THE BATTERY AND ACCIDENTALLY SWALLOWED IT. THE BATTERY CAUSED BURNS TO THE ESOPHAGUS, AND THE CHILD UNDERWENT SEVERAL SURGERIES TO REPAIR DAMAGE TO HIS ESOPHAGUS FROM THE INCIDENT. MORE MEDICAL INTERVENTION MAY BE REQUIRED. THE INSTRUCTIONS FOR USE HAVE CLEAR WARNINGS WHICH STATE, "DO NOT ALLOW CHILDREN TO TAKE THEIR TEMPERATURE UNATTENDED", "KEEP OUT OF REACH OF YOUNG CHILDREN, ELDERLY AND PETS", AS WELL AS A CLEAR INSTRUCTION TO "CAREFULLY REPLACE THE BATTERY COVER AND, USING A COIN, TIGHTEN THE COVER". IT IS UNCLEAR TO US HOW A SECURELY TIGHTENED BATTERY COMPARTMENT COULD HAVE BEEN OPENED BY A SMALL CHILD. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED FOR TESTING.