MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; WC,K4, 18",FLA,ELR, 300 LB

Catalog Number	MDS806550FLA
Medical Device Problem Codes	Activation Failure (3270); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the left armrest will not lock into place when they lower it on the wheelchair.".
Additional Manufacturer Narrative
The customer reported an issue with the left armrest and stated that the left armrest would not lock into place when lowered; no injuries reported.Video evidence provided by the customer was reviewed, and both the left and right swing-back armrests were being compared as the customer demonstrated lifting the left armrest assembly upward and attempting to place it back into the armlock assembly.The investigation results were confirmed: unlike the right armrest, which locked into place as expected, the left armrest did not lock.The left arm lock assembly appears to be incorrectly assembled onto the frame, which is causing the left armrest to fail to lock into place; based on the evidence presented in the video and the incident report, the root cause remains unknown at this time, and the division will continue to monitor for similar occurrences through 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: MEDLINE
• Common Device Name: WC,K4, 18",FLA,ELR, 300 LB
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: raveena sampathi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50884660
• Report Number: 1417592-2026-50055
• Device Sequence Number: 13450595
• Product Code: IOR
• UDI-Device Identifier: 00080196739588
• UDI-Public: 00080196739588
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/23/2026

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?: Yes
• Device Catalogue Number: MDS806550FLA
• 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: 01/12/2026
• Initial Report FDA Received Date: 09/24/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown