MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; THERMOMETER, FOREHEAD, NO TOUCH

Catalog Number	MDSNOTOUCH
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the surface and object setting is working normally, the forehead setting delivers a failure.".
Additional Manufacturer Narrative
The customer reported the mdsnotouch forehead thermometer was giving inaccurate readings during use, and that "the forehead setting delivers a failure." medline received 1ea mdsnotouch forehead thermometer in used condition and tested the sample according to the instructions for use by taking three different measurements within 1 inch from the forehead.Readings were between 97.7 and 98.1 f displaying normal function, the indicator sound was heard when all temperature measures were taken, and the complaint was not confirmed.No root cause was identified; the sample worked 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, FOREHEAD, NO TOUCH
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkata peruri ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50916453
• Report Number: 1417592-2026-52149
• Device Sequence Number: 5544773
• Product Code: FLL
• UDI-Device Identifier: 00888277637910
• UDI-Public: 00888277637910
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K122221
• 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): 09/28/2026

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: MDSNOTOUCH
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/14/2025
• 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: 10/14/2025
• 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