MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; SPRING-LOADED 4-BAR FULL SIDE RAIL F/HMC

Catalog Number	MDS89694N
Medical Device Problem Codes	Collapse (1099); Material Separation (1562); Structural Problem (2506); Material Integrity Problem (2978); Mechanical Jam (2983)
Health Effect - Clinical Code	Fall (1848)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the customer, the side rail on the bed collapsed in the middle and the black spacers in the middle came off.It was also reported that the head rest does not go up or down and there are cables sticking out.It was reported that on (b)(6), the end user fell due to issues with the bed rails.The end user went to the hospital and "was admitted for observation.No reports of injury".No additional information at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the customer, the side rail on the bed collapsed in the middle and the black spacers in the middle came off.It was also reported that the head rest does not go up or down and there are cables sticking out.

• Brand Name: MEDLINE
• Common Device Name: SPRING-LOADED 4-BAR FULL SIDE RAIL F/HMC
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: sabrina surmaj ; three lakes drive; northfield, IL 60093
• MDR Report Key: 24984356
• Report Number: 1417592-2026-00577
• Device Sequence Number: 10505651
• Product Code: FNJ
• UDI-Device Identifier: 40884389118727
• UDI-Public: 40884389118727
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: MDS89694N
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 04/24/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 53 KG