MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; WC,K1,18",FLPA,SA, 300 LB

Catalog Number	K1186N13S
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "they received a damaged chair from this order.".
Additional Manufacturer Narrative
The customer reported that their patient received the chair damaged from this order, and there was no visible damage to the shipping box upon delivery.A physical sample was not provided; a photo depicting the defect was provided and only a visual review of the defect could be conducted.Investigation results were confirmed; upon reviewing the submitted photos, the long protective plate was observed bent inward on both sides, causing the plate to make direct contact with the rear wheels when the chair is folded, and the right rear wheel appeared bent inward toward the armrest pad.Based on the evidence available and the condition of the product, it is most likely that the damage occurred during shipping; no trends were identified for the specified material number and its corresponding defect type, 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,K1,18",FLPA,SA, 300 LB
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: rahul kota ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50869493
• Report Number: 1417592-2026-48874
• Device Sequence Number: 10661454
• Product Code: IOR
• UDI-Device Identifier: 10193489001020
• UDI-Public: 10193489001020
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: K1186N13S
• 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: 01/13/2026
• Initial Report FDA Received Date: 09/23/2026
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown