MAUDE Adverse Event Report: KAZ EUROPE SÀRL BRAUN; EAR THERMOMETER

Model Number IRT3020

Device Problem Device Handling Problem (3265)

Patient Problems Fever (1858); Seizures (2063)

Event Date 01/09/2018

Event Type  Injury  

Event Description

A consumer reported that her thermometer had allegedly given inconsistent false negative readings on their son.The device allegedly gave readings that were 3°c lower than the patients actual temperature.The child had a febrile seizure and was taken by ambulance to the hospital where a high fever was confirmed.It was also alleged that the false negative readings from the device may have caused a delay in medical attention which contributed to unforeseen febrile seizures.There were no complications from this incident, and the patient is doing well now.

• Brand Name: BRAUN
• Type of Device: EAR THERMOMETER
• Manufacturer (Section D): KAZ EUROPE SÀRL; lausanne, 1003 ; SZ 1003
• Manufacturer Contact: sonja wilkinson ; 400 donald lynch boulevard; suite 300; marlborough, MA 01752 ; 5084907236
• MDR Report Key: 7293713
• MDR Text Key: 100840950
• Report Number: 1314800-2018-00007
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K103097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Patient Family Member or Friend
• Device Model Number: IRT3020
• Device Lot Number: 35216FAM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2016
• 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): Hospitalization; Other
• Patient Age: 12 MO