BRAUN BNT400

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 2019-08-06 for BRAUN BNT400 manufactured by Kaz Usa, Inc., A Helen Of Troy Company.

MAUDE Entry Details

Report Number1314800-2019-00039
MDR Report Key8864234
Report SourceCONSUMER
Date Received2019-08-06
Date of Report2019-08-05
Date Mfgr Received2019-07-08
Device Manufacturer Date2018-12-20
Date Added to Maude2019-08-06
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 Received2019-08-06
Model NumberBNT400
Lot Number35418
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 2019-08-06

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.