MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; WC, K3, 18", SB DDLA, SA

Catalog Number	K3186N24S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the wheel chair "had concealed damage to the wheel".
Additional Manufacturer Narrative
The customer reported the product was "na brand new", "in box in regular undamaged shipping box," had no shipping damage, and was received this way; per the description, the chair was received with a broken rear wheel and, per the image, the spokes of the rear wheel are broken.A photo was provided, and a physical sample was not provided; therefore only a visual review of the defect could be conducted, and a functional or dimensional inspection could not be executed via a photo.Investigation results were confirmed, and after reviewing the photo, the right rear wheel appears to have fractured spokes at the hub and the product appears to be in new condition.The investigation conclusion/root cause stated the issue is most likely due to shipping damage; no trends were identified, no product changes were identified that could have contributed to the alleged product failure, the serial number passed inspection, 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, K3, 18", SB DDLA, SA
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: ayan asim ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50755070
• Report Number: 1417592-2026-39340
• Device Sequence Number: 18490783
• Product Code: IOR
• UDI-Device Identifier: 00193489087140
• UDI-Public: 00193489087140
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 09/10/2026

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: K3186N24S
• 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: 07/02/2025
• Initial Report FDA Received Date: 09/14/2026
• 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