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

Catalog Number	MDS9950H
Medical Device Problem Codes	Unable to Obtain Readings (1516); Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the thermometer wont read his temperature most of the time.Othertimes it takes 20 minutes before he gets a read and read is never going above 96.".
Additional Manufacturer Narrative
The customer reported receiving a medline digital oral thermometer that was giving inaccurate readings during use, and reported that the thermometer would not read his temperature most of the time, other times it takes 20 minutes before he gets a read, and the read is never going above 96.Medline received one oral digital stick thermometer in used condition; the sample came with a working battery, was tested according to the instructions for use, the signaling tone was noticeable, and five body temperature readings were between 97.9 and 98.2 f.The complaint was not confirmed, and the cause was not confirmed with the received sample.The sample worked as intended, and medline was unable to confirm the complaint issue or that the product failed to meet specifications.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
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: diana arizmendi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50884411
• Report Number: 1417592-2026-50009
• Device Sequence Number: 10707891
• Product Code: SDV
• UDI-Device Identifier: 00888277116514
• UDI-Public: 00888277116514
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• 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: MDS9950H
• Device Lot Number: 240730001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/25/2025
• 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: 07/10/2025
• Initial Report FDA Received Date: 09/24/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown