MAUDE Adverse Event Report: KAZ, INC. BRAUN; THERMOMETER

Model Number FHT1000

Device Problem False Negative Result (1225)

Patient Problem Fever (1858)

Event Date 03/01/2015

Event Type  Other  

Event Description

The consumer reported their thermometer was giving false negative reading on their son.The device allegedly read 5-6 degrees fahrenheit lower than the child's actual temperature.The child was brought to a hospital, where it was confirmed that he had a fever.There was not adverse event reported, and there were no complications due to the product malfunction.The patient is doing fine now.Kaz usa, inc.Has requested that the product be returned for testing.

• Brand Name: BRAUN
• Type of Device: THERMOMETER
• Manufacturer (Section D): KAZ, INC.; 250 turnpike road; southborough MA 01772
• Manufacturer Contact: sonja wilkinson ; 250 turnpike road; southborough, MA 01772 ; 5084907236
• MDR Report Key: 4731486
• MDR Text Key: 5740521
• Report Number: 1314800-2015-00028
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/22/2015

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 Number: FHT1000
• Device Lot Number: 23914ONB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/31/2015
• Initial Date FDA Received: 04/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other