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

Catalog Number	MDS9698L
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
This vmsr report summarizes 8 malfunction events that occurred between april 1 and june 30, 2023.The account reported that temple thermometers (mds9698l) displayed error 1 codes during operation.The customer reported that 8 thermometers had exhibited the issue over a period of several months.No patient information was available.No patient or user injuries were reported.
Additional Manufacturer Narrative
This vmsr submission is part of a retrospective data remediation review.The included events represent 8 malfunction events that medline became aware of during april 1, 2023 through june 30, 2023.8 mds9698l temple thermometers were evaluated following reports that the units displayed error 1 codes during operation.Evaluation was conducted using returned samples.Based on the investigation, the reported issue could not be confirmed.Review of the available sample information determined that the units were out of warranty.Sample serial numbers 2101 and 2005 indicated manufacturing dates of 2021 and 2020, respectively.The investigation determined that the reported condition was most likely associated with normal wear and tear due to the age of the devices and the length of time in service.A specific product-related defect could not be confirmed.Replacement units were issued to the customer under order 590255083.The devices were returned for evaluation.The devices were not labeled for single use.No devices were identified as reprocessed or reused.No patient or user injuries were reported.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: 50946482
• Report Number: 1417592-2026-54269
• Device Sequence Number: 21207171
• Product Code: FLL
• UDI-Device Identifier: 00888277409937
• UDI-Public: 00888277409937
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 8
• Summary Report (Y/N): Y
• 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: MDS9698L
• 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): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown