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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 FHT1000
Device Problems Improper or Incorrect Procedure or Method (2017); Failure to Clean Adequately (4048)
Patient Problem Fever (1858)
Event Type  malfunction  
Event Description
A consumer reported that her thermometer had allegedly given a false negative reading on her daughter.The device allegedly gave readings that were 7f degrees lower than the patients actual temperature.The child was taken to the emergency room where a high 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 Key7984239
MDR Text Key124564779
Report Number1314800-2018-00028
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 Non-Healthcare Professional
Type of Report Initial
Report Date 10/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberFHT1000
Device Lot Number09814ONB
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/03/2018
Date Manufacturer Received09/18/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/08/2014
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 Age4 YR
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