MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TRANS CHAIR,ALUM,12"WHL,19" 300 LB, BLUE

Catalog Number	MDS808210ABE
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that today it got stuck and will not open.It might be the folding machanism per profuct support.
Additional Manufacturer Narrative
The customer reported the transport chair had been used for three weeks and "today it got stuck" and "will not open", and the photo/video report shows the transport chair stuck in the folded position.Medline received two transport chairs and, upon assembly, both chairs had no physical damage to the frame or upholstery; the folding paddle mechanisms locked and unlocked the backrests properly, the footrests secured onto the mounting pins and locked in place, and the hand brakes functioned as intended.Upon investigation, the folding mechanism for both chairs opened and closed with ease, and the customer complaint has not been confirmed.No root cause was identified, and additional recommendations were none.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: TRANS CHAIR,ALUM,12"WHL,19" 300 LB, BLUE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: raveena sampathi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50931004
• Report Number: 1417592-2026-52848
• Device Sequence Number: 9508936
• Product Code: INM
• UDI-Device Identifier: 40884389150802
• UDI-Public: 40884389150802
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/25/2026

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: MDS808210ABE
• Device Lot Number: 15122110001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/09/2023
• 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: 06/08/2023
• Initial Report FDA Received Date: 09/29/2026
• 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