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

Catalog Number	MDS806850
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "one of the brand new wheelchairs from po 1092338 come back after one call due to a patient sitting in it and the frame bending.".
Additional Manufacturer Narrative
The customer reported that one of the brand-new wheelchairs came back after one call due to a patient sitting in it and the frame bending.A physical sample was not provided; photos were provided and only a visual review of the defect could be conducted, and the right side lower frame tubing that connects to the front right fork appears to be slightly bent above the front wheel.The investigation results were confirmed.Given the evidence provided in the photos, as well as the incident report, the root cause of this issue is unknown, and the division will monitor this issue 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: vamshi pinnamshetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50945753
• Report Number: 1417592-2026-54132
• Device Sequence Number: 13369287
• Product Code: IOR
• UDI-Device Identifier: 00080196132877
• UDI-Public: 00080196132877
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 12/15/2025
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2025
• 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