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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KAZ USA, INC., A HELEN OF TROY COMPANY BRAUN; FOREHEAD THERMOMETER
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KAZ USA, INC., A HELEN OF TROY COMPANY BRAUN; FOREHEAD THERMOMETER Back to Search Results
Model Number FHT1000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fever (1858); Seizures (2063)
Event Date 10/02/2018
Event Type  Injury  
Event Description
A consumer reported that her thermometer had allegedly given "inconsistant" false negative readings on their child.The device allegedly gave readings that were 5°f lower than what was measured at a later time at a hospital.The child has a febrile seizure and was taken to the hospital via ambulance where a fever was confirmed.There were no complications from this incident, and the patient is doing well now.
 
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Brand Name
BRAUN
Type of Device
FOREHEAD THERMOMETER
Manufacturer (Section D)
KAZ USA, INC., A HELEN OF TROY COMPANY
marlborough MA 01752
Manufacturer Contact
sonja wilkinson
400 donald lynch boulevard
suite 300
marlborough, MA 01752
5084907236
MDR Report Key8046710
MDR Text Key126402332
Report Number1314800-2018-00032
Device Sequence Number1
Product Code FLL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K033820
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberFHT1000
Device Lot NumberILLEGIBLE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/17/2018
Initial Date Manufacturer Received 10/08/2018
Initial Date FDA Received11/07/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention;
Patient Age5 YR
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