MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; LIFT,PATIENT,HYDRAULIC,6 POINT CRADLE

Catalog Number	MDS88200D
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "caregiver trip over lift and noticed the lift base was bent.".
Additional Manufacturer Narrative
The customer stated that the caregiver tripped over the lift and noticed the lift base was bent; no harm to the patient was reported.Medline received one base for lift in used condition; all four wheels were worn and dirty, the brakes on the rear wheels functioned properly, the tie rods were undamaged, and based on the photos provided, the unit was assembled properly.Upon investigation, the right leg of the base was bent up, causing the right front wheel to be lifted off the ground, and the customer complaint has been confirmed.Given the information provided, the root cause of this issue is unknown, 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: LIFT,PATIENT,HYDRAULIC,6 POINT CRADLE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: donovan frazier ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50872163
• Report Number: 1417592-2026-49257
• Device Sequence Number: 15808848
• Product Code: FSA
• UDI-Device Identifier: 40080196764250
• UDI-Public: 40080196764250
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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: MDS88200D
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/18/2025
• 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: 01/15/2025
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown