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 2020-02-12 for BRAUN NTF3000 manufactured by Kaz Usa, Inc., A Helen Of Troy Company.

MAUDE Entry Details

Report Number1314800-2020-00009
MDR Report Key9699212
Report SourceCONSUMER
Date Received2020-02-12
Date of Report2020-02-10
Date of Event2020-01-15
Date Mfgr Received2020-01-15
Device Manufacturer Date2014-12-19
Date Added to Maude2020-02-12
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 MA 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 Received2020-02-12
Model NumberNTF3000
Lot Number35314TAV
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. Other; 2. Required No Informationntervention 2020-02-12

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