MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TRANS CHAIR, 22", RDLA,SA, NYLON, 450 LB

Catalog Number	TCB228N21S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "left hand side handle that holds the left arm rest on metal part has broken off the seat are and doesn not stay down.Second issue is right hand brake is slipping".
Additional Manufacturer Narrative
The customer reported frame damage and stated that the left-hand side handle that holds the left arm rest on metal part has broken off the seat are and does not stay down; the customer also reported the right-hand brake is slipping and needs replacement.A physical sample was not provided; a photo depicting the defect was provided and a visual review was conducted, and it was discovered that the weld that holds the holster for the armrest was fractured and the outer coating of paint above the right front wheel is chipped as if it was hit by something.The investigation results were confirmed.Given the evidence provided in the photo, as well as the incident report, the root cause of this issue is unknown; no product changes were identified that could have contributed to the alleged product failure, 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: TRANS CHAIR, 22", RDLA,SA, NYLON, 450 LB
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: vamshi pinnamshetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50871208
• Report Number: 1417592-2026-49162
• Device Sequence Number: 13089934
• Product Code: INM
• UDI-Device Identifier: 00193489036810
• UDI-Public: 00193489036810
• 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): 09/23/2026

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: TCB228N21S
• Device Lot Number: 16424050001
• 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: 03/10/2025
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2024
• 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