MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP GUARDIAN; WC, K4, 16", SB DDLA, ELR

Catalog Number	K4166N24E
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Fall (1848); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Limb Pain (4836)
Date of Event	05/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2026 while seated in the device and attempting to put on a "compression sock," the wheel "came off" and the individual fell to the floor.The customer also reported that "part of the wheelchair collapsed onto" the user's left foot.Per the customer, the individual had left foot surgery "10 weeks ago." the customer described two silver nuts "had detached from the chair." the customer stated that she "experienced pain and swelling on the top" of the "left foot." the customer sought medical attention from their orthopedic surgeon who diagnosed a "soft tissue injury" and was instructed to remain "non-weight bearing" and "elevate and ice" the injury.No additional information is available at this time.It has been determined that though the event did not involve a death or serious injury, recurrence could cause or contribute to death or serious injury.Based on the information reviewed, this is a reportable event as defined under 21 cfr 803.3.
Event or Problem Description
According to the customer, on (b)(6) 2026 while seated in the device and attempting to put on a "compression sock," the wheel "came off" and the individual fell to the floor.The customer also reported that "part of the wheelchair collapsed onto" the user's left foot.

• Brand Name: GUARDIAN
• Common Device Name: WC, K4, 16", SB DDLA, ELR
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: jessica walter ; three lakes drive; northfield, IL 60093
• MDR Report Key: 25302631
• Report Number: 1417592-2026-01844
• Device Sequence Number: 9319224
• Product Code: IOR
• UDI-Device Identifier: 00193489099679
• UDI-Public: 00193489099679
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/27/2026

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: K4166N24E
• Device Lot Number: 16425090001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2025
• 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 Age: 78 YR
• Patient Sex: Female
• Patient Weight: 68 KG