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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "when i purchased the item, i tried to use it as a forehead, the monitor and it kept registering low." it was also reported that "i still cannot get the four head thermometer to work.".
Additional Manufacturer Narrative
The customer reported that when they tried to use the thermometer as a forehead monitor, it kept registering low, and after changing the batteries, they still could not get the forehead thermometer to work.Complaint could not be confirmed as there were no samples or pictures received.Without a sample received it is difficult to determine a true root cause for the reported issue.Should the sample/detailed picture become available, the complaint will be reopened and investigated accordingly.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
• Manufacturer Contact: william abrams ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50944873
• Report Number: 1417592-2026-54013
• Device Sequence Number: 18754845
• Product Code: FLL
• UDI-Device Identifier: 00080196406404
• UDI-Public: 00080196406404
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 05/19/2023
• 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: Unknown