MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; LIFT,PATIENT,ELECTRIC,600LB CAPACITY

Catalog Number	MDS600ELB
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ¿we have a lift at our (b)(6) location that is bent on the frame by the wheels.¿.
Additional Manufacturer Narrative
Per the description, the customer states that the lift has a bent frame by the rear wheels; per the images, the main frame that the rear caster and boom attach to is bent.Medline reviewed photo evidence provided by the customer; a physical sample was not provided, and only a visual review of the defect can be conducted.The investigation results were confirmed, and it was discovered that the base portion above the left rear wheel appears to be bent upwards.The cause was documented as ¿cannot determine cause w/received sample¿; no product changes were identified that could have contributed to the alleged product failure, no corrective/preventive action was taken, and the division will monitor complaints 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: LIFT,PATIENT,ELECTRIC,600LB CAPACITY
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: madelyn ruppert ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50771650
• Report Number: 1417592-2026-40325
• Device Sequence Number: 21464882
• Product Code: FSA
• UDI-Device Identifier: 10193489019261
• UDI-Public: 10193489019261
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 09/14/2026

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: MDS600ELB
• Was Device Available for Evaluation?: Yes
• 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: 11/20/2024
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown