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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 Problems False Negative Result (1225); Use of Device Problem (1670); Patient Device Interaction Problem (4001)
Patient Problem Fever (1858)
Event Date 05/03/2021
Event Type  malfunction  
Event Description
A consumer reported that their thermometer had allegedly given false negative readings on her daughter.The device allegedly gave readings that were 5°f lower than what was later measured at a hospital.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 Key11916209
MDR Text Key264606731
Report Number1314800-2021-00008
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 06/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberFHT1000
Device Catalogue NumberFHT1000US
Device Lot Number13314ONB
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/27/2021
Date Manufacturer Received05/12/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/13/2014
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) Other; Required Intervention;
Patient Age2 YR
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