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

Model Number FHT1000

Device Problem False Negative Result (1225)

Patient Problem Fever (1858)

Event Date 11/09/2015

Event Type  malfunction  

Event Description

The consumer reported their thermometer was giving false negative readings on their child.The device allegedly was reading 5-6 degrees lower than the child's actual temperature.The consumer claims that the child was seen by a doctor, where it was confirmed that they had a fever.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: 5338035
• MDR Text Key: 34918355
• Report Number: 1314800-2015-00083
• 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: 12/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2015
• 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: 11/23/2015
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention