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

Catalog Number	MDSNOTOUCH
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "right away after putting in new batteries screen read "low" and will not change.".
Additional Manufacturer Narrative
The complaint reported that the member believed they received a defective item and that, after putting in new batteries, the screen read "low" and would not change.The customer no longer had the sample, and no samples, photos, videos, or other critical details were provided; a retrospective review of the complete complaint file was conducted.Complaint could not be confirmed as there were no samples or pictures received, and medline was unable to confirm the complaint issue or that the product failed to meet specifications.Without a sample received it is difficult to determine a true root cause for the reported issue; no trends were identified for the corresponding defect type, and if a sample, photo and/or additional information becomes available this complaint will be reopened to be further investigated.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: joseph weiske ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50945398
• Report Number: 1417592-2026-54070
• Device Sequence Number: 9499588
• Product Code: FLL
• UDI-Device Identifier: 00888277637910
• UDI-Public: 00888277637910
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 09/29/2026

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: MDSNOTOUCH
• Was Device Available for Evaluation?: No
• 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: 04/11/2023
• 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