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

Model Number FHT1000

Device Problem False Negative Result (1225)

Patient Problems Fever (1858); Viral Infection (2248)

Event Date 12/14/2015

Event Type  malfunction  

Event Description

The consumer reported their thermometer was giving false negative readings on their infant son.The device allegedly was reading 4-5 degrees lower than the child's actual temperature.The consumer claims that the child was taken to the er, where it was confirmed he had a viral infection and a fever of 103.2 f.There were no complications from this incident , and the child is doing well.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.; marlborough MA 01752
• Manufacturer Contact: sonja wilkinson ; 400 donald lynch blvd; suite 300; marlborough, MA 01752 ; 5084907236
• MDR Report Key: 5366336
• MDR Text Key: 36044711
• Report Number: 1314800-2016-00003
• 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,health professional
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 12/15/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 4 MO