MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; THERMOMETER,TEMPLE,6-10 SECOND

Catalog Number	MDS9698L
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that they do not work.Every time we go to use them they error out.
Additional Manufacturer Narrative
The account reported finding error message, and it was reported that the thermometers did not function as expected and that an error code occurred each time the devices were used.A photograph and product samples were provided; review of the photograph showed the device was observed to power on, after which error 1 appeared on the display, and two returned samples displayed error 1 during startup before control batteries were installed and valid readings were obtained.Complaint was confirmed.Finished good production records reviewed found no abnormalities, the cause was documented as cannot determine cause with received sample, and after replacing the batteries and allowing the devices to remain powered off for a short duration, the thermometers functioned as intended.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,TEMPLE,6-10 SECOND
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: nicholas kourkine ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50913218
• Report Number: 1417592-2026-51787
• Device Sequence Number: 12200679
• Product Code: FLL
• UDI-Device Identifier: 00888277409937
• UDI-Public: 00888277409937
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K103617
• 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): 09/23/2026

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: MDS9698L
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/10/2026
• 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: 02/23/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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