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

Model Number	IRT3030US
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Codes	Fever (1858); Unspecified Kidney or Urinary Problem (4503)
Date of Event	09/09/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 1314800-2022-00016
• Device Sequence Number: 16831642
• Product Code: FLL
• UDI-Device Identifier: 00328785000146
• UDI-Public: 00328785000146
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K161933
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: IRT3030US
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 12 MO
• Patient Sex: Prefer Not To Disclose