MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; WC, XW, 26", RDLA, ELR, 500 LB

Catalog Number	KX268V21E
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the fork assembly for the front left wheel is shredded" and "a damaged bearing housing".
Additional Manufacturer Narrative
The customer stated that the fork assembly for the front left wheel is shredded but he does not know exactly how it happened and reported a damaged bearing housing.Medline received one wheelchair that was the replacement unit and photos; upon receiving the replacement unit, the left plastic bracket for the armrest pad was fractured, the rest of the unit was intact and functioned properly, and the original physical sample was not provided for investigation.Based on the photo evidence of the original unit, the product appears to be in used condition, the fork assembly metal bearings appear to have fractured, and the customer complaint has been confirmed.No trends were identified for the specified material number and its corresponding defect type, and the division will monitor through trending.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, 26", RDLA, ELR, 500 LB
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kim evangelista ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50899017
• Report Number: 1417592-2026-51087
• Device Sequence Number: 5853083
• Product Code: IOR
• UDI-Device Identifier: 00193489179951
• UDI-Public: 00193489179951
• 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): 09/25/2026

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: KX268V21E
• Device Lot Number: 16425030001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/22/2026
• 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: 01/08/2025
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2025
• 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