MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; BED, FULL ELECTRIC, MEDLITE, 450 LB

Catalog Number	MDR107003L
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the right side of the foot section is not lifting up" and "the footboard has a broken pulley.When using the hi/lo function, one side of the footboard will raise and the other side does not.".
Additional Manufacturer Narrative
The customer reported the right side of the foot section is not lifting up, and that the footboard has a broken pulley; when using the hi/lo function, one side of the footboard will raise and the other side does not.Medline received one bed "footboard only" in used condition, and upon further investigation of the sample it was discovered that when tested the footboard went up on only one side; after removing the plastic panels, one of the plastic pulleys was fractured and the cable slipped off, with no damage to the other pulleys, cables, slip clutch, or the plastic panels.The investigation results were confirmed, and the pic testing result was functional defect.The cause was documented as cannot determine cause with received sample; the division will monitor through quarterly 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: BED, FULL ELECTRIC, MEDLITE, 450 LB
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: william abrams ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50870331
• Report Number: 1417592-2026-49058
• Device Sequence Number: 10674572
• Product Code: FNL
• UDI-Device Identifier: 40080196294344
• UDI-Public: 40080196294344
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 09/23/2026

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: MDR107003L
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/24/2024
• 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: 06/07/2024
• Initial Report FDA Received Date: 09/23/2026
• 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