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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Fever (1858)
Event Date 01/30/2018
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 a false negative reading on her daughter.The device allegedly gave a reading that was 4.9° f lower than the patient's actual temperature.The child was taken to the doctor where a high fever of 104.4°f 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.
 
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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 01752
Manufacturer Contact
sonja wilkinson
400 donald lynch boulevard
suite 300
marlborough, MA 01752
5084907236
MDR Report Key7319886
MDR Text Key101730271
Report Number1314800-2018-00012
Device Sequence Number1
Product Code FLL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K134043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 03/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Patient Family Member or Friend
Device Model NumberBFH150
Device Lot Number16617TAV
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/05/2018
Initial Date FDA Received03/07/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/15/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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