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

Catalog Number	MDS9698L
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "customer is getting an error message of error 1 which would indicate that this item is not at room temp.Customer believe this is defective as she has another one of this and has not recevived this error message before".
Additional Manufacturer Narrative
The customer reported error 1 message and stated that the item is not at room temp.Medline received 1 instant read digital temple thermometer in used condition with 2 aaa working batteries, tested the sample according to the instructions for use, sanitized the thermometer¿s probe sensor and attempted to test the sample several more times, and replaced and inserted 2 new aaa batteries.The complaint was confirmed; no temperature readings were displayed, the thermometer would only display an "er 1" message, and replacing the batteries did not solve the issue.Issue shown via investigation was caused due to a functional malfunction, and the sample did not work 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: jarred meyers ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50898547
• Report Number: 1417592-2026-51009
• Device Sequence Number: 20296707
• Product Code: FLL
• UDI-Device Identifier: 00888277409937
• UDI-Public: 00888277409937
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/24/2026

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: 10/28/2024
• 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: 10/18/2024
• Initial Report FDA Received Date: 09/25/2026
• 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