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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 Type  Injury  
Manufacturer Narrative
Kaz usa, inc.Has requested that the product be returned to our company for testing, but it has not yet been received.
 
Event Description
A consumer reported that her thermometer had allegedly given a false negative reading on her grandson a few months ago.The device allegedly gave a reading that was 4.8°f lower than the patients actual temperature.The child had a febrile seizure and was taken to the hospital by ambulance where a high fever was confirmed.There were no complications from this incident, and the patient is doing well now.Kaz usa, inc.Has requested that the product be returned to our company for testing.
 
Event Description
A consumer reported that her thermometer had allegedly given a false negative reading on her grandson a few months ago.The device allegedly gave a reading that was 4.8°f lower than the patients actual temperature.The child had a febrile seizure and was taken to the hospital by ambulance where a high 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
MDR Report Key8735703
MDR Text Key149238380
Report Number1314800-2019-00034
Device Sequence Number1
Product Code FLL
Combination Product (y/n)N
PMA/PMN Number
K033820
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 07/11/2019
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 Lay User/Patient
Device Model NumberFHT1000
Device Lot Number34415ONB
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/08/2019
Initial Date Manufacturer Received 05/30/2019
Initial Date FDA Received06/26/2019
Supplement Dates Manufacturer Received05/30/2019
Supplement Dates FDA Received07/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age2 YR
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