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

Model Number FHT1000

Device Problem Low Readings (2460)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/29/2014

Event Type  Other  

Event Description

The consumer reported their thermometer was giving false negative readings on their child.The device allegedly read 4-5 degrees lower than the child's actual temperature when taken by a nurse at school.There were no complications from this incident, and the pt is going fine now.

• Brand Name: BRAUN
• Type of Device: THERMOMETER
• Manufacturer (Section D): KAZ, INC.; 250 turnpike rd; southborough MA 01772
• Manufacturer Contact: sonja wilkinson ; 250 turnpike rd; southborough, MA 01772 ; 5084907236
• MDR Report Key: 4209000
• MDR Text Key: 5043251
• Report Number: 1314800-2014-00074
• 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: 10/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2014
• 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: 09/29/2014
• 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): Other