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

Catalog Number	MDS88200D
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bolt for the tie rod to the lift is sheared off.
Additional Manufacturer Narrative
Customer reported that the bolt for the tie rod sheared off and the customer believes this is a frame issue.A photo was provided; a physical sample was not provided, and only a visual review of the defect could be conducted, not a functional or dimensional inspection.Investigation results were confirmed; after reviewing the photo, the left tie rod bolt appears to have fractured off from the center of the base, and the cause was recorded as cannot determine cause w/received sample.No credit or replacement was issued; corrective/preventive action was not taken.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: veera karravula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50839752
• Report Number: 1417592-2026-46025
• Device Sequence Number: 9949711
• Product Code: FSA
• UDI-Device Identifier: 40080196764250
• UDI-Public: 40080196764250
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 09/18/2026

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
• 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: 02/04/2025
• Initial Report FDA Received Date: 09/21/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown