MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; WC,K1,VINYL,18",FLA,ELR, 300 LB

Catalog Number	K1186V11E
Medical Device Problem Codes	Fracture (1260); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "rear wheel arrived with broken spokes" and there was an "issue with the front wheel not steering correctly.".
Additional Manufacturer Narrative
The customer is stating that "the left rear wheel arrived with broken spokes, and the right front wheel is not steering properly"; the complaint states the issue did not occur during use and no injury occurred.Medline reviewed the video and photo evidence provided by the customer; 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 confirmed: the right front caster appeared to be hitting the frame tubing, preventing it from swiveling; the frame tubing leading to the front caster was bent backwards; and the plastic spokes on the left rear wheel appeared to have fractured.The product appeared to be in new condition, and the issue was most likely due to shipping damage; no trends were identified for the specified material number and its corresponding defect type.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: WC,K1,VINYL,18",FLA,ELR, 300 LB
• 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: 50898368
• Report Number: 1417592-2026-50983
• Device Sequence Number: 21522876
• Product Code: IOR
• UDI-Device Identifier: 10193489021875
• UDI-Public: 10193489021875
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K990463
• 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): 09/24/2026

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: K1186V11E
• 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: 02/13/2026
• Initial Report FDA Received Date: 09/25/2026
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown