MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; RAIL,SIDE,HEAD SECTION,SOFT TOUCH

Catalog Number	FCE1232RSRN
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "rails were delivered damaged" and "the rail will not move.".
Additional Manufacturer Narrative
The customer reported that the rails were delivered damaged with no shipping damage, and per the sales rep, the rail will not move.Medline received one bed "head section side rail" in new condition, and upon inspection was able to move the rail up, lock it in place, and lower it again; initially, the mechanism was somewhat stiff but loosened with repeated use.The investigation results were not confirmed, and the customer complaint could not be confirmed; no root cause was identified.No other issues were observed, and the division will continue monitoring through trending.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: RAIL,SIDE,HEAD SECTION,SOFT TOUCH
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: brianna montgomery ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50793160
• Report Number: 1417592-2026-42753
• Device Sequence Number: 18495705
• Product Code: FNL
• UDI-Device Identifier: 10080196313877
• UDI-Public: 10080196313877
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 09/15/2026

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: FCE1232RSRN
• Device Lot Number: 54125010001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/13/2025
• 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: 05/16/2025
• Initial Report FDA Received Date: 09/16/2026
• 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