MAUDE Adverse Event Report: Medline Industries, LP GUARDIAN; WC, K4, 20", SB DDLA, ELR

Catalog Number	K4206N24E
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the right axel got bent" and "the whole wheel being bent.".
Additional Manufacturer Narrative
The customer reported that the right axel got bent and later stated that the axle that was sent did not fit due to the whole wheel being bent; no injuries were reported.A physical sample was not provided, and photos were reviewed; the product appeared to be in used condition, the axle bolt for the left rear wheel appeared to be slightly bent, and additional photos showed the rear wheel axle appeared to not be properly aligning with or passing through the bearings with visible scratching around the bearing area.The investigation results were confirmed.Given the evidence provided in the photos and the incident report, the root cause of this issue is unknown, and no trends or product changes were identified that could have contributed to the alleged product failure.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: GUARDIAN
• Common Device Name: WC, K4, 20", SB DDLA, ELR
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: vamshi thupakula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50896296
• Report Number: 1417592-2026-50716
• Device Sequence Number: 10684154
• Product Code: IOR
• UDI-Device Identifier: 00193489099754
• UDI-Public: 00193489099754
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/24/2026

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: K4206N24E
• 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: 05/30/2025
• Initial Report FDA Received Date: 09/25/2026
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown