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

Model Number FHT1000

Device Problem Low Readings (2460)

Patient Problems Seizures (2063); Misdiagnosis (2159)

Event Type  Other  

Event Description

The consumer reported their thermometer was giving false negative readings on their child.The device allegedly was reading 3 degrees lower than the child's actual temperature, and the consumer stated that this caused a delay in medical attention.The child suffered a seizure and was treated at a hospital, where it was confirmed that they had a fever.

• Brand Name: BRAUN
• Type of Device: THERMOMETER
• Manufacturer (Section D): KAZ USA, INC.; 250 turnpike road; southborough MA 01772
• Manufacturer Contact: sonja wilkinson ; 250 turnpike road; southborough, MA 01772 ; 5084907236
• MDR Report Key: 4890821
• MDR Text Key: 6829430
• Report Number: 1314800-2015-00040
• 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: 05/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: FHT1000
• Device Catalogue Number: N/A
• Device Lot Number: 13214ONB
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/19/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• 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): Hospitalization