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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; EAR THERMOMETER
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KAZ USA, INC., A HELEN OF TROY COMPANY BRAUN; EAR THERMOMETER Back to Search Results
Model Number IRT4520
Device Problems False Negative Result (1225); Use of Device Problem (1670); 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 her thermometer had allegedly given false negative readings on her daughter.The device allegedly gave readings that were 3.2°f lower than what was measured at a later time by a doctor where a fever and 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 false negative readings on her daughter.The device allegedly gave readings that were 3.2°f lower than what was measured at a later time by a doctor where a fever and 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
EAR THERMOMETER
Manufacturer (Section D)
KAZ USA, INC., A HELEN OF TROY COMPANY
marlborough MA 01752
MDR Report Key9330487
MDR Text Key191269699
Report Number1314800-2019-00050
Device Sequence Number1
Product Code FLL
Combination Product (y/n)N
PMA/PMN Number
K103800
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 12/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberIRT4520
Device Lot Number05213K09374
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/21/2019
Date Manufacturer Received10/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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