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

Catalog Number	MDSTS101H
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the anesthesia provider stated the medline product was off by a full degree, therefore are not accurate.".
Additional Manufacturer Narrative
A complaint was received, and the customer reported receiving a medline forehead strip thermometer that is off by a full degree; there was no reported death or serious injury associated with this event.Medline received a 100 pack of mdsts101 and two photos from the customer; the photographs showed the strips being compared while not being on the center of the forehead, and testing resulted in 96.8f for both control and test strips sent in by customer, with an oral thermometer result of 97.5f.Per the instructions for use, these readings are within the 1.0f accuracy, and the complaint is not confirmed.Based on the review of the details provided for the complaint investigation, medline was unable to confirm the complaint issue or that the product failed to meet specifications.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: THERM,STRIP,FOREHEAD,DISP, 100 EA/PK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: shirisha mothe ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50870299
• Report Number: 1417592-2026-49047
• Device Sequence Number: 10674037
• Product Code: KPO
• UDI-Device Identifier: 10888277681958
• UDI-Public: 10888277681958
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 09/23/2026

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: MDSTS101H
• Device Lot Number: L250630009
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/13/2025
• 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: 10/08/2025
• Initial Report FDA Received Date: 09/23/2026
• 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