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

Model Number IRT-3520

Device Problem Low Readings (2460)

Patient Problem No Code Available (3191)

Event Date 04/08/2014

Event Type  Other  

Event Description

The consumer reported their thermometer was giving a false negative reading.The device was reading in the normal range despite the child having a fever.The consumer took their child to the doctor where her temperature was taken and it was confirmed they had fever.There were no complications from the incident, and the child is dong fine now.

• Brand Name: BRAUN
• Type of Device: THERMOMETER
• Manufacturer (Section D): KAZ USA INC.; 240 turnpike rd; southborough MA 01772
• Manufacturer (Section G): KAZ USA INC; 250 turnpike road; southborough MA 01772
• Manufacturer Contact: sonja wilkinson ; 250 turnpike road; southborough, MA 01772 ; 5084907236
• MDR Report Key: 3788334
• MDR Text Key: 4444661
• Report Number: 1314800-2014-00043
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983295
• 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: 04/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: IRT-3520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/09/2014
• 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