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

Catalog Number	K4206N24S
Medical Device Problem Codes	Fracture (1260); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "there seems to be damage to the frame, backrest, and seat.".
Additional Manufacturer Narrative
The customer states that there is damage to the frame, seat and back rest, and the folding/support mechanism underneath the chair is cracked and appears to be missing hardware.Medline reviewed the photo evidence provided by the customer, pcn history, and quality control inspection records; the product appeared to be in used condition, the backrest upholstery appeared ripped at the seam, the seat appeared to have dirt and scratches, and the folding/support mechanism underneath the chair appears fractured.The investigation results were confirmed.Given the evidence provided in the photo the root cause of this issue is unknown; no product changes were identified that could have contributed to the alleged product failure, no corrective/preventive action was taken, and the division will monitor 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, 20", SB DDLA, SA
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: nathan bersch ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50819656
• Report Number: 1417592-2026-44802
• Device Sequence Number: 13423976
• Product Code: IOR
• UDI-Device Identifier: 00193489099761
• UDI-Public: 00193489099761
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/17/2026

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: K4206N24S
• Device Lot Number: 16422040001
• 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: 11/25/2024
• Initial Report FDA Received Date: 09/18/2026
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown