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

Catalog Number	KX228V21S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Fall (1848)
Date of Event	08/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while the end user was using the chair the r "rim" rear wheel spokes broke near the center hub causing the end user to fall to the ground.
Additional Manufacturer Narrative
The customer is stating that "when being pushed in a parking lot, 3 of 6 spokes in the right tire broke causing the end-user to fall out of the chair"; the customer reported the end-user did not sustain any injuries during the event.Sample and/or photo provided? not available; a call tag was issued to have the defected unit returned for investigation, and at this time the sample has yet to be received.Investigation results: not confirmed; the cause code was updated to unconfirmed defect - sample required to determine cause.No product changes were identified that could have contributed to the alleged product failure, and there has been no change to the reportability decision associated with this complaint.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, SA, 500 LB
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: haroon mian ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50897727
• Report Number: 1417592-2026-50895
• Device Sequence Number: 6001056
• Product Code: IOR
• UDI-Device Identifier: 00193489179920
• UDI-Public: 00193489179920
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: KX228V21S
• 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: 08/28/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Weight: 353 LB