MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; WC, XW, 22", RDLA, ELR, 500 LB

Catalog Number	KX228V21E
Medical Device Problem Codes	Fracture (1260); Dent in Material (2526); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "wheelchair received with a damaged wheel right out of the box.".
Additional Manufacturer Narrative
The customer reported that the wheelchair was received with a damaged wheel right out of the box.A photo was provided, and a visual review of the defect was conducted; a physical sample was not provided and a functional or dimensional inspection could not be executed via a photo.The investigation results were confirmed, and the photo showed the outer hub of one of the rear wheels was fractured across approximately half of its diameter, with scratches visible on the inner hub and a small dent near the location of the fracture.The product appeared to be in new condition, and the issue was most likely due to shipping damage.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, XW, 22", RDLA, ELR, 500 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: 50945798
• Report Number: 1417592-2026-54141
• Device Sequence Number: 13373535
• Product Code: IOR
• UDI-Device Identifier: 00193489179913
• UDI-Public: 00193489179913
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 09/28/2026

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: KX228V21E
• 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: 09/02/2025
• Initial Report FDA Received Date: 09/30/2026
• 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