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

Catalog Number	K3186N44E1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that plastic piece that goes into armrest from wheelchair has fractured.
Additional Manufacturer Narrative
The customer reported frame damage and stated that the plastic piece that goes into armrest from wheelchair has fractured; the issue occurred during use while the customer was in the wheelchair, and no injury occurred.A photo was provided, and after reviewing the photo, it was discovered that the right rear arm rest holster is fractured; a physical sample was not provided, so only a visual review of the defect could be conducted and a functional or dimensional inspection could not be executed via a photo.The investigation results were confirmed, the root cause of this issue is unknown, 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 HARFLA, ELR
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: shravan ingole ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50947524
• Report Number: 1417592-2026-54455
• Device Sequence Number: 21207090
• Product Code: IOR
• UDI-Device Identifier: 00193489142931
• UDI-Public: 00193489142931
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 09/29/2026

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: K3186N44E1
• Device Lot Number: 16425100002
• 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: 01/16/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown