MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; THERMOMETER, LARGE DISPLAY, F/C

Catalog Number	MDS9953H
Medical Device Problem Codes	Computer Software Problem (1112); No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "thermometer is giving a low message and is also not beeping.".
Additional Manufacturer Narrative
The customer reported that the thermometer was not working properly, was giving a low message, and was also not beeping.Medline received one digital thermometer in used condition with a working battery, sanitized the sample, tested it according to the instructions for use, observed the signaling tone after the "lo" sign was displayed, and took five measurements with temperature readings between 97.5 and 98.0 f.The complaint was not confirmed; medline experienced no indications of malfunctions, inaccurate readings, power issues, or the absence of the signaling tone being heard, and the cause code description was not confirmed with received sample.The "lo" sign is not an error message, but rather an indicator that the thermometer is ready to use, and the sample worked 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, LARGE DISPLAY, F/C
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: vamshi pinnamshetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50872429
• Report Number: 1417592-2026-49303
• Device Sequence Number: 21188533
• Product Code: FLL
• UDI-Device Identifier: 00888277701482
• UDI-Public: 00888277701482
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K193621
• 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: MDS9953H
• Device Lot Number: 240330008
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/22/2024
• 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: 10/08/2024
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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