MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; THERMOMETER,DIGITAL,ORAL,F/C,30 SEC,BULK

Catalog Number	MDS9950B
Medical Device Problem Codes	Computer Software Problem (1112); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "they have been shutting down prior to measuring the temperature.".
Additional Manufacturer Narrative
The reported product problem issue was shuts off during use, and the customer reported receiving a medline thermometer that has shuts off during use.Medline received one instant read digital thermometer in used condition; the thermometer came with a working battery, was sanitized, and was tested according to the instructions for use, and the temperature readings were within range of each other.The complaint was not confirmed, and medline experienced no indications of power issues, malfunctions, inaccurate readings, or the absence of the signaling tone being heard.No root cause was identified; the sample worked as intended, and medline will continue to monitor this issue for 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,DIGITAL,ORAL,F/C,30 SEC,BULK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: joseph weiske ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50841502
• Report Number: 1417592-2026-46348
• Device Sequence Number: 10060040
• Product Code: FLL
• UDI-Device Identifier: 00888277115630
• UDI-Public: 00888277115630
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 09/21/2026

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: MDS9950B
• Device Lot Number: L240530002
• Was Device Available for Evaluation?: Yes
• 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: 01/03/2025
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown