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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 NTF3000
Device Problem False Negative Result (1225)
Patient Problem Fever (1858)
Event Date 08/21/2023
Event Type  malfunction  
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 multiple false negative readings on her child.The device allegedly gave readings around 94-96°f, and a fever of 102.0°f was later confirmed in an emergency room.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.
 
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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 Key17819367
MDR Text Key324286100
Report Number1314800-2023-00012
Device Sequence Number1
Product Code FLL
UDI-Device Identifier00328785000306
UDI-Public00328785000306
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K163516
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 09/26/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberNTF3000
Device Lot Number19820TAV
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/30/2023
Initial Date FDA Received09/26/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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 Age3 YR
Patient SexMale
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