MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP MEDLINE GUARDIAN; WC, K3, 18", SB HARFLA, SA

Catalog Number	K3186N44S
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
"the armrest are cracking and the wheelchair wobbles when the end user is in it.".
Additional Manufacturer Narrative
It was reported that "the armrest are cracking and the wheelchair wobbles".It was reported that the user has "bruising on his arms from using the wheelchair and is going to a doctor tomorrow as he is experiencing pain on other areas of his body from sitting in the wheelchair".It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: MEDLINE GUARDIAN
• Common Device Name: WC, K3, 18", SB HARFLA, SA
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 24967857
• Report Number: 1417592-2026-00552
• Device Sequence Number: 21456643
• Product Code: IOR
• UDI-Device Identifier: 00193489088222
• UDI-Public: 00193489088222
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 04/23/2026

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?: No
• Device Catalogue Number: K3186N44S
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2025
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 85 KG