MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; LIFT,PAT,HYDRAULIC,6 POINT CRD,NO SLING

Catalog Number	MDS88200HL
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the wheel with the brake on left side is broken and the ball bearings have came out.
Additional Manufacturer Narrative
The customer stated the wheel with the brake on left side is broken and the ball bearings have come out, and per customer, the ball bearings came out of the left rear caster.A photo was provided; a physical sample was not provided, so only a visual review of the defect could be conducted, and a functional or dimensional inspection could not be executed via a photo.The investigation results were not confirmed; after reviewing the photo it was discovered that the issue cannot be identified based on the photo provided.No root cause was identified; no product changes were identified that could have contributed to the alleged product failure, quality control inspection records were reviewed, and corrective/preventive action was not taken because the division will initiate further investigation and/or supplier corrective action requests based on trending results.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,PAT,HYDRAULIC,6 POINT CRD,NO SLING
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: diana arizmendi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50771289
• Report Number: 1417592-2026-40295
• Device Sequence Number: 13133734
• Product Code: FSA
• UDI-Device Identifier: 40884389144825
• UDI-Public: 40884389144825
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 09/10/2026

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: MDS88200HL
• 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: 07/06/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown