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

Catalog Number	MDS808210ABE
Medical Device Problem Codes	Corroded (1131); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the legrest lever broke right off.This would be the left side.
Additional Manufacturer Narrative
The customer contacted medline regarding their transport chair and stated ¿the legrest lever broke right off¿; the complaint noted this was the left side, the customer had only used the chair 3-4 times, and ¿no fall or injury reported.¿ a physical sample was not provided; photos of the left footrest were provided and only a visual review of the defect could be conducted, and medline discovered that the left footrest's upper mounting plate with the locking clip has fractured off the footrest at the weld, which also appears to have some corrosion.The investigation results were confirmed.Given the evidence provided in the photo there is a possibility this issue could be due to contact with water or excess moisture, which is cautioned against in the product manual; the updated cause code is defect confirmed: unknown responsible party, cannot determine cause w/received sample, and no corrective/preventive action was taken with additional recommendations: 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: shravan ingole ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50949913
• Report Number: 1417592-2026-54769
• Device Sequence Number: 16039541
• Product Code: INM
• UDI-Device Identifier: 40884389150802
• UDI-Public: 40884389150802
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Was Device Available for Evaluation?: No
• 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: 10/18/2023
• 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