MAUDE Adverse Event Report: KAZ, INC. BRAUN

Model Number FHT1000

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

Patient Problem Fever (1858)

Event Date 09/02/2015

Event Type  Injury  

Event Description

A consumer reported that their thermometer was giving false negative readings on their child.The device allegedly was reading 2-3 degrees lower than the child's actual temperature.The child suffered a febrile seizure and was treated at a hospital, where it was confirmed that the pt had a fever.There was no complications from this incident, and the child is doing well.Kaz usa, inc, has requested that the device be returned to our company for testing.

• Brand Name: BRAUN
• Manufacturer (Section D): KAZ, INC.; marlborough MA 01772
• Manufacturer Contact: sonja wilkinson ; 400 donald lynch blvd.; ste. 300; marlborough, MA 01752 ; 5084907236
• MDR Report Key: 5207269
• MDR Text Key: 30632915
• Report Number: 1314800-2015-00073
• 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: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: FHT1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Required Intervention
• Patient Age: 1 YR