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

Model Number IRT-4520

Device Problem Low Readings (2460)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2014

Event Type  Other  

Event Description

The consumer reported that their thermometer was giving a false negative reading.The device was reading in the normal range despite their daughter having a fever.The consumer took her 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 doing fine now.

• Brand Name: BRAUN
• Type of Device: THERMOMETER
• Manufacturer (Section D): KAZ, INC.; 250 turnpike road; southborough MA 01772
• Manufacturer (Section G): KAZ, INC.; one vapor trail; hudson NY 12534
• Manufacturer Contact: sonja wilkinson ; 250 turnpike road; southborough, MA 01772 ; 5084907236
• MDR Report Key: 3780970
• MDR Text Key: 4431737
• Report Number: 1314800-2014-00032
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031928
• 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: 04/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: IRT-4520
• Device Lot Number: 02313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2013
• 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