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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 BFH175
Device Problems False Negative Result (1225); Insufficient Information (3190)
Patient Problem Fever (1858)
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 his thermometer had allegedly given false negative readings on her son.The device allegedly gave a readings that were 7.5°f lower than what was later measured by their pediatrician.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 his thermometer had allegedly given false negative readings on her son.The device allegedly gave a readings that were 7.5°f lower than what was later measured by their pediatrician.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 Key9756689
MDR Text Key191268205
Report Number1314800-2020-00010
Device Sequence Number1
Product Code FLL
UDI-Device Identifier00328785001679
UDI-Public00328785001679
Combination Product (y/n)N
PMA/PMN Number
K181015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 03/12/2020
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 Lay User/Patient
Device Model NumberBFH175
Device Lot Number20818TAV
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/28/2020
Initial Date Manufacturer Received 01/27/2020
Initial Date FDA Received02/26/2020
Supplement Dates Manufacturer Received01/27/2020
Supplement Dates FDA Received03/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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