MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; THERM,STRIP,FOREHEAD,DISP, 100 EA/PK

Catalog Number	MDSTS101H
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	03/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that they do not work.
Additional Manufacturer Narrative
The customer reported that the strips "do not work," and medline requested additional information.The complaint could not be confirmed as there was no sample/photo/video/lot number/other critical details provided, even after follow-ups with the customer.Medline was unable to confirm the issue or that the product failed to meet specifications; without a sample received it is difficult to determine a root cause, and the documented cause was "sample required to determine cause." the division performs quarterly trending on all complaints received.The complaint will be reopened and reevaluated if a sample/photo and/or additional information becomes available.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.This 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 reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: THERM,STRIP,FOREHEAD,DISP, 100 EA/PK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50846314
• Report Number: 1417592-2026-46943
• Device Sequence Number: 9901488
• Product Code: KPD
• UDI-Device Identifier: 10888277681958
• UDI-Public: 10888277681958
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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): 09/21/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: MDSTS101H
• 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: 03/27/2024
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown