MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; RAIL,SIDE,HEAD SECTION,SOLD AS PAIR

Catalog Number	FCE1232RSR
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that "half rail is very hard to move.It gets stuck when repositioning it down and back to up position".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.
Event or Problem Description
It was reported "half rail is very hard to move.It gets stuck when repositioning it down and back to up position".

• Brand Name: MEDLINE
• Common Device Name: RAIL,SIDE,HEAD SECTION,SOLD AS PAIR
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; 3 lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nitish sandadi ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25524325
• Report Number: 1417592-2026-02161
• Device Sequence Number: 5533311
• Product Code: FNL
• UDI-Device Identifier: 40080196289081
• UDI-Public: 40080196289081
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/16/2026

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: FCE1232RSR
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown