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	03/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the right foot pedal is loose and continues to fall down when she tries to put her foot on it.She believes it may be stripped.".
Additional Manufacturer Narrative
The customer stated that the right foot pedal is loose and continues to fall down when she tries to put her foot on it, and she believes it may be stripped.A physical sample was not provided; a photo depicting the defect was provided and only a visual review of the defect could be conducted, and after reviewing the photos it was discovered that there is a fracture in the footrest at the top coming out from where the plastic is molded to go around the frame tubing of the footrest.The investigation results were confirmed.Given the evidence provided in the photo the root cause of this issue is unknown; no trends were identified for the specified defect type, and inspection results did not identify any nonconformances that correspond to the defect reported in this complaint.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: herchelle teodoro ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50946559
• Report Number: 1417592-2026-54288
• Device Sequence Number: 18729190
• Product Code: IOR
• UDI-Device Identifier: 00193489142924
• UDI-Public: 00193489142924
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/29/2026

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
• 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: 03/25/2026
• Initial Report FDA Received Date: 09/30/2026
• 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