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

Model Number FHT1000

Device Problems False Negative Result (1225); Low Test Results (2458)

Patient Problems Fever (1858); Seizures (2063)

Event Date 05/13/2015

Event Type  Other  

Event Description

The consumer reported their thermometer was giving false negative readings on their child.The device allegedly was reading 3.5 degrees lower than the child's actual temperature.The child suffered a seizure and was treated at a hosp, where it ws confirmed that they had a fever.Kaz usa, inc.Has requested that the product be returned to our company for testing.

• Brand Name: BRAUN
• Type of Device: THERMOMETER
• Manufacturer (Section D): KAZ USA, INC.; 250 turnpike rd; southborough MA 01772
• Manufacturer Contact: sonja wilkinson ; 250 turnpike rd; southborough, MA 01772 ; 5084907236
• MDR Report Key: 4821520
• MDR Text Key: 16308445
• Report Number: 1314800-2015-00047
• 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: Other
• Type of Report: Initial
• Report Date: 06/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: FHT1000
• Device Lot Number: 22113ONB
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• 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): Hospitalization
• Patient Age: 6 YR