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

Model Number FHT1000

Device Problems False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Fever (1858)

Event Date 09/20/2014

Event Type  Other  

Event Description

The consumer reported their thermometer was giving false negative readings on their infant.The device allegedly read 3 degrees lower than the child's actual temperature.The consumer took her daughter to the emergency room where it was confirmed that the child had a high grade fever.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 USA, INC.; 250 turnpike rd; southborough MA 01772
• Manufacturer Contact: sonja wilinson ; 250 turnpike rd; southborough, MA 01772 ; 5084907236
• MDR Report Key: 4187575
• MDR Text Key: 5091548
• Report Number: 1314800-2014-00071
• 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: 09/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2014
• 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: 09/22/2014
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 9 MO