MAUDE Adverse Event Report: Medline Industries, LP GUARDIAN; WC,PED,14,SB-DLA,SA,250 LB

Catalog Number	KPD4N22S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the left rear drive wheel is broken there are cracks all around it and they are unable to use it.".
Additional Manufacturer Narrative
The customer reported that "the left rear drive wheel is broken, there are cracks all around it, and they are unable to use it." a physical sample was not provided; photos were provided and only a visual review of the defect could be conducted.Based on the photo evidence, the product appears to be in used condition due to dirt and grime buildup on the rear wheel spokes, and several wheel spokes appear to have fractured at the center of the rear wheel hub and around the axle.The investigation results were confirmed, the root cause of this issue is unknown, no trends were identified, and the division will monitor 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: GUARDIAN
• Common Device Name: WC,PED,14,SB-DLA,SA,250 LB
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: aaron ginsburg ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50897630
• Report Number: 1417592-2026-50880
• Device Sequence Number: 13438212
• Product Code: IOR
• UDI-Device Identifier: 10193489037647
• UDI-Public: 10193489037647
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K053574
• 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: KPD4N22S
• 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: 03/13/2026
• 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