MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; WC, K3, 16", SB HARFLA, ELR

Catalog Number	K3166N44E1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the plastic bit of the armrest that has broken".
Additional Manufacturer Narrative
Per photo and customer report, item received with a plastic piece broken off the armrest assembly.Photo was provided, a physical sample was not provided, and only a visual review of the defect can be conducted; after reviewing the photos it was discovered that they show that the quick-release paddle for the swing back armrest on the left hand side fractured off of the arm.Investigation results: confirmed.The product appears to be in new condition, it was received this way; therefore, this issue is most likely due to shipping damage, and no product changes were identified that could have contributed to the alleged product failure.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, K3, 16", SB HARFLA, ELR
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkata peruri ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50913627
• Report Number: 1417592-2026-51819
• Device Sequence Number: 12094807
• Product Code: IOR
• UDI-Device Identifier: 00193489142924
• UDI-Public: 00193489142924
• 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): 09/15/2026

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: K3166N44E1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/13/2024
• 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: 02/22/2024
• Initial Report FDA Received Date: 09/28/2026
• 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