MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP GUARDIAN; WC, K4, 18", SB DDLA, ELR

Catalog Number	K4186N24E
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the "wheelchair legrest is broken and weld came undone on the right legrest bracket that connects to the chair".
Additional Manufacturer Narrative
It was reported that "wheelchair legrest is broken"."the weld came undone on the right legrest bracket that connects to the chair"."the bracket that has the lock on it"."the chair was not being used at the time.They noticed while taking the legrests off to place it in the car." 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.

• Brand Name: GUARDIAN
• Common Device Name: WC, K4, 18", SB DDLA, ELR
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield 60093 2753
• Manufacturer Contact: venkata peruri ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25400256
• Report Number: 1417592-2026-02015
• Device Sequence Number: 10718981
• Product Code: IOR
• UDI-Device Identifier: 00080196306117
• UDI-Public: 00080196306117
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K990463
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/04/2026

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: K4186N24E
• Device Lot Number: 16425040001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown