MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; LO FULL ELC BED, 450 LB

Catalog Number	MDR107003LO
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "on the right side of the footboard, the leg will not lift up.Everything else is raising fine except for this corner.".
Additional Manufacturer Narrative
The customer reported that the right side of the footboard was not lifting up and everything else was raising fine except for this corner.Medline received one unit consisting of the headboard and footboard only in used condition due to visible scratches and smudges, inspected the unit per pic-00371, and tested the headboard, which continues to function properly, raising and lowering as designed.The customer's complaint has been confirmed; upon inspection, the right side does not elevate in sync with the left side.After removing the panel, medline found that the cable pulley had become dislodged and the pulley axle was bent, likely due to uneven weight distribution; this issue will be tracked by the division for trending purposes.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: LO FULL ELC BED, 450 LB
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: raveena sampathi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50948128
• Report Number: 1417592-2026-54548
• Device Sequence Number: 18749174
• Product Code: LLI
• UDI-Device Identifier: 40080196325901
• UDI-Public: 40080196325901
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/29/2026

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: MDR107003LO
• 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: 06/16/2025
• Initial Report FDA Received Date: 09/30/2026
• 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