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

Catalog Number	MDS88200D
Medical Device Problem Codes	Material Twisted/Bent (2981); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "one of the wheels is damaged.It looks like the wheel bearings got crimped at the manufacturer.".
Additional Manufacturer Narrative
The customer reported that some patient lifts were delivered and, when they went to assemble, one of the wheels was damaged and it looked like the wheel bearings got crimped at the manufacturer; the issue did not occur during use and no injury occurred.Medline reviewed video evidence provided by the customer; a physical sample was not provided, so only a visual review could be conducted, and finished good/component trending and quality control inspection records were reviewed.The investigation results were confirmed.After reviewing the video, it was discovered that the front right caster wheel does not freely rotate and gets jammed while turning compared to the left caster wheel, likely due to the wheel being bent during shipping; the product appeared to be in new condition, and this issue was most likely due to shipping damage.No trends were identified for the specified material number and corresponding defect type, and a replacement caster was issued.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: sullivan bluhm ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50913677
• Report Number: 1417592-2026-51823
• Device Sequence Number: 5393988
• Product Code: FSA
• UDI-Device Identifier: 40080196764250
• UDI-Public: 40080196764250
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/28/2026

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: 11/18/2025
• Initial Report FDA Received Date: 09/28/2026
• 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