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

Catalog Number	FCE1232RSRN
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "rep & customer both express difficulty with moving the rail up and down" and "for installing the rail, the rail must be opened to mount it to the side of the bed.".
Additional Manufacturer Narrative
The customer reported difficulty with moving the rail up and down and mentioned that, for installing the rail, the rail must be opened to mount it to the side of the bed.Medline received one pair of side rails in used condition; the 4 rods, 4 bolts, and 8 c clips for mounting were not received, there were several scratches on the frame, the locking paddles functioned properly, and when the side rail was installed on a bed and tested for function, it required force in order to fully open and close.The customer complaint has been confirmed.There was debris and coating chipping at the pivot points, however the root cause of this issue is unknown; per design, the side rails need to be in the opened position in order to mount onto the bed, therefore this is not a quality issue, and the division will monitor 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 -275
• Manufacturer Contact: shivani gheewala ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50754176
• Report Number: 1417592-2026-39181
• Device Sequence Number: 9148852
• Product Code: FNL
• UDI-Device Identifier: 10080196313877
• UDI-Public: 10080196313877
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 09/09/2026

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: 11/18/2025
• 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: 08/29/2025
• Initial Report FDA Received Date: 09/14/2026
• 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