MAUDE Adverse Event Report: Kaz USA, Inc., a Helen of Troy Company Braun; Ear Thermometer

Model Number	IRT6575
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	Fever (1858)
Date of Event	08/21/2026
Type of Reportable Event	Malfunction

• Brand Name: Braun
• Common Device Name: Ear Thermometer
• Manufacturer (Section D): Kaz USA, Inc., a Helen of Troy Company; marlborough MA 01752
• Manufacturer Contact: bethany lee ; 400 donald lynch boulevard; suite 300; marlborough, MA 01752 ; +1(508)490-7247
• MDR Report Key: 50888896
• Report Number: 1314800-2026-00024
• Device Sequence Number: 21288602
• Product Code: FLL
• UDI-Device Identifier: 00328785007909
• UDI-Public: 00328785007909
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K103800
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: IRT6575
• Device Lot Number: 05426K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2026
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 2 MO
• Patient Sex: Female