MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; THERMOMETER, FOREHEAD, NO TOUCH

Catalog Number	MDSNOTOUCH
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	Fever (1858)
Date of Event	01/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported the thermometer was "not giving a proper reading" and showed the customer did not have a fever, but the customer had a fever when they went to their doctor and the thermometer still showed no fever after leaving the doctor.Medline received 2ea mdsnotouch, with batteries included in used condition; upon visual inspection there were no cosmetic defects nor damage to the device, and functional testing was performed with readings of 98.8, 98.7 and 98.7 98.8.Both values were within range, and as a result the complaint was not confirmed.The cause code was updated to reflect unconfirmed defect - not confirmed with received sample, and no further action was taken because objectionable trends were not seen for this issue.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.
Event or Problem Description
It was reported that "its not giving a proper reading.Thermometer showed customer did not have a fever but customer had a fever when they went to their doctor.Customer stated they tested again with the thermometer after leaving their doctor and thermometer still showed no fever.".

• Brand Name: MEDLINE
• Common Device Name: THERMOMETER, FOREHEAD, NO TOUCH
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: konstantina callas ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50915493
• Report Number: 1417592-2026-52010
• Device Sequence Number: 12094838
• Product Code: FLL
• UDI-Device Identifier: 00888277637910
• UDI-Public: 00888277637910
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K122221
• 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: MDSNOTOUCH
• 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: 01/27/2023
• Initial Report FDA Received Date: 09/28/2026
• 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