MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; THERMOMETER, TALKING, EAR/FOREHEAD, HOME

Catalog Number	MDSTH1002
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	Fall (1848)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the reading on her thermometer is off.Said she had a fever of 99.3, but was getting a reading of 92 when using the ear feature.".
Additional Manufacturer Narrative
It was reported that the talking ear/forehead thermometer that was giving incorrect readings during use; no injuries reported.At this time, a sample was not received for investigation, and no lot/serial number was provided; investigation included review of recent complaint trends/scar activity for the last three trend reports, and no trends were identified for the specified material number and its corresponding defect type.Investigation results: unconfirmed; the complaint was not confirmed due to the fact that this issue can only be confirmed by further investigating the sample or a provided photo of the defect reported.Cause: sample required to determine cause; division will continue to monitor trends, and if the sample is received at a later date, this investigation will be reopened.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: THERMOMETER, TALKING, EAR/FOREHEAD, HOME
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkat gaanuthula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50947773
• Report Number: 1417592-2026-54484
• Device Sequence Number: 13136415
• Product Code: FLL
• UDI-Device Identifier: 00080196406404
• UDI-Public: 00080196406404
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K100488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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
• Device Catalogue Number: MDSTH1002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Patient Sex: Female