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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); Use of Device Problem (1670); Insufficient Information (3190); Device Handling Problem (3265)
Patient Problem Fever (1858)
Event Date 12/04/2018
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 false negative readings on her daughter.The device allegedly gave readings that were 4.8°f lower than what was measured at a later time at a doctor's office.There were no complications from this incident, and the child 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 her daughter.The device allegedly gave readings that were 4.8°f lower than what was measured at a later time at a doctor's office.There were no complications from this incident, and the child 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
MDR Report Key8216801
MDR Text Key132786643
Report Number1314800-2019-00002
Device Sequence Number1
Product Code FLL
Combination Product (y/n)N
PMA/PMN Number
K163516
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 03/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberBFH150
Device Lot Number34017TAV
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/14/2019
Date Manufacturer Received12/05/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age22 MO
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