MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; THERMOMETER, TALKING, EAR/FOREHEAD, HOME

Catalog Number	MDSTH1002
Medical Device Problem Codes	Computer Software Problem (1112); Failure to Shut Off (2939)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "put the batteries in it and it hasnt turned off since, the screen does not go black, the last tempature reading and time stays on 24/7 unless batteries are taken out.".
Additional Manufacturer Narrative
The customer reported the thermometer "hasnt turned off since," "the screen does not go black," and "the last tempature reading and time stays on 24/7 unless batteries are taken out." medline received the thermometer and, upon functional testing, found it did respond to all function that were input by using the buttons it provides; however, it did stay on at all time, and as soon as the batteries went in to the device it would stay on till batteries were removed.The complaint was confirmed.The updated cause code is defect confirmed: unknown responsible party, cannot determine cause w/received sample; no further action was taken because objectionable trends were not seen for this issue, and division has been informed and will continue to monitor trends.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, TALKING, EAR/FOREHEAD, HOME
• 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: 50899650
• Report Number: 1417592-2026-51185
• Device Sequence Number: 5829100
• Product Code: FLL
• UDI-Device Identifier: 00080196406404
• UDI-Public: 00080196406404
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K100488
• 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: MDSTH1002
• 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: 12/27/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown