BRAUN NTF3000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-03-21 for BRAUN NTF3000 manufactured by Kaz Usa, Inc., A Helen Of Troy Company.

Event Text Entries

[139471801] Kaz usa, inc. Has requested that the product be returned to our company for testing, but it has not yet been received.
Patient Sequence No: 1, Text Type: N, H10


[139471802] A consumer reported that his thermometer had allegedly given inconsistent false negative readings on their daughter which may have delayed medical attention. The device allegedly gave readings that were 3. 5 - 4? 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1314800-2019-00018
MDR Report Key8440936
Report SourceCONSUMER
Date Received2019-03-21
Date of Report2019-03-21
Date of Event2019-02-17
Date Mfgr Received2019-02-21
Date Added to Maude2019-03-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSONJA WILKINSON
Manufacturer Street400 DONALD LYNCH BOULEVARD SUITE 300
Manufacturer CityMARLBOROUGH 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5084907236
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBRAUN
Generic NameFOREHEAD THERMOMETER
Product CodeFLL
Date Received2019-03-21
Model NumberNTF3000
Lot NumberUNKNOWN
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerKAZ USA, INC., A HELEN OF TROY COMPANY
Manufacturer AddressMARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Other; 3. Required No Informationntervention 2019-03-21

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