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

Model Number FHT1000

Device Problem False Negative Result (1225)

Patient Problems Fever (1858); Pneumonia (2011)

Event Date 02/01/2015

Event Type  Other  

Event Description

The consumer reported their thermometer was giving false negative readings on their son.The device allegedly read gave a normal oral reading, but a fever of 104.3 was taken with a different (rectal) thermometer in the home.The child was brought to the hospital, where it was confirmed that they had a fever.The child was diagnosed with pneumonia, which was treated in the hospital.Kaz has requested that the product be returned 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: 4720282
• MDR Text Key: 5581873
• Report Number: 1314800-2015-00026
• 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: 04/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 03/25/2015
• Initial Date FDA Received: 04/15/2015
• 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): Other