MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; SKIN SENSOR W/400 SERIES TEMP

Catalog Number	DYNJASK400SK
Medical Device Problem Codes	Disconnection (1171); Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "temp probe continues to fail during surgeries" with "failed readings, temp head disconnecting or falling off during procedures.".
Additional Manufacturer Narrative
The customer reported "temp probe continues to fail during surgeries" and described "failed readings, temp head disconnecting or falling off during procedures." no sample or photo was received for the investigation, and trending was reviewed with 0 additional reported complaint(s) for this issue for the account in the past 24 months.Due to not receiving the actual sample used, medline was not able to confirm what may have caused the issue.The division will monitor for trends, and the complaint was provided to the vendor for further evaluation.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: SKIN SENSOR W/400 SERIES TEMP
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: ayan asim ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50931609
• Report Number: 1417592-2026-52923
• Device Sequence Number: 9508971
• Product Code: FLL
• UDI-Device Identifier: 10080196551774
• UDI-Public: 10080196551774
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K111282
• 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: DYNJASK400SK
• Device Lot Number: 1176
• Was Device Available for Evaluation?: No
• 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: 03/11/2025
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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