MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; WC, K4, 20", SB DDLA, ELR

Catalog Number	K4206N24E
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the armrests do not go all the way out to the front.
Additional Manufacturer Narrative
The customer stated that the armrests do not go all the way out to the front and that he was trying to purchase the full length armrests to add to his unit.Sample and/or photo was not available; finished good/component trending was performed and no trends were identified for the specified material number and its corresponding defect type, and quality control inspection records were reviewed.The investigation results were not confirmed, as the customer received the correct armrest for the unit, which comes with desk-length armrest, and no defect is present.The root cause was preference/item to spec, traced to user, and the division will continue to monitor this issue through quarterly trending to identify any patterns or recurring problems.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, 20", SB DDLA, ELR
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: rizwan shaik ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50870315
• Report Number: 1417592-2026-49053
• Device Sequence Number: 21501257
• Product Code: IOR
• UDI-Device Identifier: 00193489099754
• UDI-Public: 00193489099754
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 09/22/2026

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: K4206N24E
• Was Device Available for Evaluation?: No
• 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: 02/18/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown