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

Catalog Number	MDS9953H
Medical Device Problem Code	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the thermometer "does not alarm any more, does not alarm after reading is done".It was also reported that "it is not beeping.He held the button for 180 seconds and did not hear a beep".
Additional Manufacturer Narrative
The customer reported no alarm after reading is done and also stated it is not beeping and he held the button for 180 seconds and did not hear a beep.Medline received two digital thermometers in used condition with working battery, sanitized the samples, tested them according to the instructions for use, and took two different measurements per thermometer.The complaint was not confirmed; the signaling tone was noticeable after the lo sign was displayed, heard at the end of every test, and audible when the samples were turned off.The cause was documented as not confirmed with received sample, 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: madelyn ruppert ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50931875
• Report Number: 1417592-2026-52969
• Device Sequence Number: 9563571
• Product Code: FLL
• UDI-Device Identifier: 00888277701482
• UDI-Public: 00888277701482
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/25/2026

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: L230130008
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/19/2024
• 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: 02/08/2024
• Initial Report FDA Received Date: 09/29/2026
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown