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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 BFH150
Device Problems False Negative Result (1225); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem Fever (1858)
Event Date 03/18/2020
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 false negative readings on herself.The device allegedly gave readings that were 4°f lower than what was later measured by their doctor.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.
 
Event Description
A consumer reported that her thermometer had allegedly given false negative readings on herself.The device allegedly gave readings that were 4°f lower than what was later measured by their doctor.There were no complications from this incident, and the patient is doing well now.
 
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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
MDR Report Key9978916
MDR Text Key191267683
Report Number1314800-2020-00019
Device Sequence Number1
Product Code FLL
Combination Product (y/n)N
PMA/PMN Number
K134043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 05/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberBFH150
Device Lot Number34116TAV
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/06/2020
Date Manufacturer Received03/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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