MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TRANSPORT CHAIR, KNOCKDOWN, STEEL

Catalog Number	MDS808200KD
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the hole on the frame that connects to the wheels is warped/too small to connect the wheels.".
Additional Manufacturer Narrative
The customer reported the transport chair was "just taken out box at time of delivery" and that it was received this way with the opening on the frame to attach the wheels warped/too small to connect the wheels.Medline received the sample in new condition and, upon assembly, the folding mechanism operated smoothly, the push handles locked securely into place, and the front casters were able to be properly inserted into their holsters and secured using the hand screws.The investigation results were confirmed for the rear holster and not confirmed for the front holster; the rear wheel assembly could not be inserted into its holster due to bent tubing on both sides, with visible scuffs on the rear leg frame tubing.The damage observed may have occurred during shipping, and the division will monitor complaints through quarterly 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: TRANSPORT CHAIR, KNOCKDOWN, STEEL
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kumar vigrahala ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50898567
• Report Number: 1417592-2026-51012
• Device Sequence Number: 14959069
• Product Code: INM
• UDI-Device Identifier: 00888277329983
• UDI-Public: 00888277329983
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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): 09/24/2026

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: MDS808200KD
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/03/2025
• 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: 04/09/2025
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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