MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TRANS CHAIR,19", DLA, SA, 300 LB

Catalog Number	MDS808200F3CC
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the left lever brake broke off.
Additional Manufacturer Narrative
Per caller, the left lever brake broke off; this happened a a few months ago when his father (now deceased) was using it, caller doesn't know exactly how it broke, and no injuries were reported.A photo depicting the defect was provided and only a visual review of the defect was conducted; a functional or dimensional inspection could not be executed via a photo, and a physical sample was not provided.Investigation results were not confirmed, and the issue of the fractured lever could not be confirmed from the photo because the issue could not be identified based on the photos provided.No product changes were identified that could have contributed to the alleged product failure, the cause was cannot determine cause w/received sample, and the division will monitor complaints through quarterly 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,19", DLA, SA, 300 LB
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: jarred meyers ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50900357
• Report Number: 1417592-2026-51261
• Device Sequence Number: 6026671
• Product Code: INM
• UDI-Device Identifier: 00193489037183
• UDI-Public: 00193489037183
• 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): 09/24/2026

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: MDS808200F3CC
• 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: 12/18/2024
• Initial Report FDA Received Date: 09/25/2026
• 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