BRAUN FHT1000

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 2020-01-03 for BRAUN FHT1000 manufactured by Kaz Usa, Inc., A Helen Of Troy Company.

MAUDE Entry Details

Report Number1314800-2020-00001
MDR Report Key9545758
Report SourceCONSUMER
Date Received2020-01-03
Date of Report2020-01-14
Date of Event2019-12-09
Date Mfgr Received2019-12-09
Device Manufacturer Date2020-03-07
Date Added to Maude2020-01-03
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 Received2020-01-03
Returned To Mfg2020-01-07
Model NumberFHT1000
Lot Number06615ONB
OperatorLAY USER/PATIENT
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
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 2020-01-03

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