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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 FHT-1000
Device Problems Device Reprocessing Problem (1091); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Fever (1858)
Event Date 07/31/2017
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 son.The device allegedly consistently gave readings that were 4.9f degrees lower than the patients actual temperature.The child was taken to see a pediatrician where a fever 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.
 
Event Description
A consumer reported that her thermometer had allegedly given a false negative reading on her son.The device allegedly consistently gave readings that were 4.9f degrees lower than the patients actual temperature.The child was taken to see a pediatrician where a fever was confirmed.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 01752
Manufacturer Contact
sonja wilkinson
400 donald lynch boulevard
suite 300
marlborough, MA 01752
5084907236
MDR Report Key6830851
MDR Text Key83989138
Report Number1314800-2017-00040
Device Sequence Number1
Product Code FLL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K033820
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,Followup
Report Date 10/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Patient Family Member or Friend
Device Model NumberFHT-1000
Device Lot Number22413ONB
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/19/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received07/31/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/12/2013
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;
Patient Age6 YR
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