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

Catalog Number	MDS808210ABE
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the seat is broken, the plastic piece that keeps it stable broke apart.".
Additional Manufacturer Narrative
The customer stated "the plastic piece that keeps it stable broke apart," and reported a broken seat guide.A physical sample was not provided; photos of the seat guide were provided and only a visual review of the defect could be conducted because a functional or dimensional inspection cannot be executed via a photo.The investigation results were confirmed; after reviewing the photos it was discovered that the left plastic seat guide has come loose within the seat tube and is protruding farther out than expected, therefore it cannot lock the seat in place.Given the evidence provided in the photo the root cause of this issue is unknown, 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,ALUM,12"WHL,19" 300 LB, BLUE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: shravan ingole ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50951894
• Report Number: 1417592-2026-55047
• Device Sequence Number: 9534803
• Product Code: INM
• UDI-Device Identifier: 40884389150802
• UDI-Public: 40884389150802
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: MDS808210ABE
• Device Lot Number: 15122060004
• 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: 08/29/2023
• Initial Report FDA Received Date: 09/30/2026
• 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