MAUDE Adverse Event Report: KAZ USA, INC., A HELEN OF TROY COMPANY BRAUN; EAR THERMOMETER

Model Number IRT3030US

Device Problem False Negative Result (1225)

Patient Problems Fever (1858); Unspecified Kidney or Urinary Problem (4503)

Event Date 09/09/2022

Event Type  malfunction  

Manufacturer Narrative

Kaz usa, inc.Had requested that the product be returned to our company for testing, but the device has not yet been received.

Event Description

A consumer reported that her thermometer had allegedly given false negative readings on her baby.It was stated that our device gave a reading of 98.2°f, but three hours later a different household thermometer read 103.0°f.The child was later taken to the doctor where a fever and kidney infection were confirmed.It was stated that the low readings given by our device allegedly may have caused a delay in medical attention.There were no complications from this incident, and the patient is doing well now.Kaz usa, inc.Had requested that the product be returned to our company for testing, but the device has not yet been received.

• Brand Name: BRAUN
• Type of Device: EAR THERMOMETER
• Manufacturer (Section D): KAZ USA, INC., A HELEN OF TROY COMPANY; marlborough MA 01752
• Manufacturer Contact: sonja wilkinson ; 400 donald lynch boulevard; suite 300; marlborough, MA 01752 ; 5084907236
• MDR Report Key: 15589543
• MDR Text Key: 307070038
• Report Number: 1314800-2022-00016
• Device Sequence Number: 1
• Product Code: FLL
• UDI-Device Identifier: 00328785000146
• UDI-Public: 00328785000146
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IRT3030US
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/12/2022
• 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): Required Intervention; Other
• Patient Age: 12 MO
• Patient Sex: Prefer Not To Disclose