MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TRANSPORT CHAIR,BASIC, 19" 300 LB

Catalog Number	MDS808200KWM
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Damaged Thread (4075)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the front left assembly wheel woobly and it looks like is bent" and "the screw reaches a certain point and does not stop it just keeps turning.".
Additional Manufacturer Narrative
The customer reported that the front left assembly wheel was wobbly and looked bent, and after product support requested tightening the hand screw that holds the front wheel assembly in place, the customer responded, "tried that and the screw reaches a certain point and does not stop it just keeps turning"; no injuries were reported.Medline reviewed the photo and video evidence provided by the customer, noted the product appeared to be in used condition due to wear of the wheels, and determined that the customer showed the left front wheel and stated it was loose although it was never demonstrated.The investigation results were not confirmed, and a physical sample was not provided; only a visual review could be conducted and a functional or dimensional inspection could not be executed via a photo.No root cause was identified, 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,BASIC, 19" 300 LB
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sullivan bluhm ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50936501
• Report Number: 1417592-2026-53602
• Device Sequence Number: 9734557
• Product Code: INM
• UDI-Device Identifier: 00193489038265
• UDI-Public: 00193489038265
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/29/2026

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: MDS808200KWM
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/06/2025
• 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: 05/30/2025
• Initial Report FDA Received Date: 09/29/2026
• 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