MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; WC,EXCEL,22",RDLA,ELR,NAVY, 500 LB

Catalog Number	MDS806850
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the "rear tube" for the right armrest broke off - the one that is welded to the frame.He said that the frame is severed.
Additional Manufacturer Narrative
The customer is reporting a broken frame on the wheelchair, and the complaint stated that the rear tube for the right armrest broke off, the one that is welded to the frame; no fall or injury occurred.A physical sample was not provided; a photo depicting the defect was provided and only a visual review of the defect could be conducted.Investigation results were confirmed, and after reviewing the photo, the right rear armrest holster/receiver appeared to be fractured at the weld where it connects to the main frame tubing.Given the evidence provided in the photo, as well as the incident report, the root cause of the reported issue cannot be determined at this time, and the division will monitor complaints through quarterly 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,EXCEL,22",RDLA,ELR,NAVY, 500 LB
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: zelek alexander ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50935397
• Report Number: 1417592-2026-53491
• Device Sequence Number: 15829883
• Product Code: IOR
• UDI-Device Identifier: 00080196132877
• UDI-Public: 00080196132877
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 09/28/2026

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: MDS806850
• 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: 03/09/2026
• Initial Report FDA Received Date: 09/29/2026
• 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