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

Catalog Number	MDS808200KNM
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that "the chair has a stripped hand screw for left front wheel, she was trying to push her husband on the wheelchair and the wheel kept falling off so she didn't use it, they discovered the screw was stripped, she swapped the screws to verify the screw is stripped and not the hole".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.
Event or Problem Description
It was reported that "the chair has a stripped hand screw for left front wheel".

• Brand Name: MEDLINE
• Common Device Name: TRANSPORT CHAIR,BASIC, 19" 300 LB
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: juan mota ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25715563
• Report Number: 1417592-2026-04274
• Device Sequence Number: 5142143
• Product Code: INM
• UDI-Device Identifier: 00193489038258
• UDI-Public: 00193489038258
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/06/2026

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: MDS808200KNM
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown