MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; WC,K1,18",SB DLA,SA, 300 LB

Catalog Number	K1186N22S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the wheelchair was received with a broken rear wheel.Attached are pictures of damaged wheel rim and serial numbers.
Additional Manufacturer Narrative
The customer stated that the wheelchair was received with a broken rear wheel, and the complaint described a damaged wheel rim.A photo depicting the defect was provided; a physical sample was not provided, and only a visual review of the defect could be conducted.The investigation results were confirmed, and the photo review observed that the hub of the rear left wheel was fractured, resulting in one spoke becoming dislodged and three others being 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 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,K1,18",SB DLA,SA, 300 LB
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: diana arizmendi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50868406
• Report Number: 1417592-2026-48718
• Device Sequence Number: 10716021
• Product Code: IOR
• UDI-Device Identifier: 00193489001061
• UDI-Public: 00193489001061
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 09/23/2026

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: K1186N22S
• Device Lot Number: 16424090001
• 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: 07/09/2025
• Initial Report FDA Received Date: 09/23/2026
• 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