MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TRANSPORT CHAIR, KNOCKDOWN, STEEL

Catalog Number	MDS808200KD
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "when customer was trying to remove the right legrest he noticed the welding on the top clip/hook to attach it to the unit is broken off.The welding on it snapped off.".
Additional Manufacturer Narrative
The customer reported a damaged footrest, and that when customer was trying to remove the right leg rest, he noticed the welding on the top clip/hook to attach it to the unit is broken off.A physical sample was not provided; a photo depicting the defect was provided and only a visual review of the defect could be conducted, and the product appears to be in used condition.The investigation results were confirmed, and after reviewing the photos it was discovered that the upper pin plate of the right-side leg rest has fractured off of the leg rest.Given the evidence provided in the complaint and photos, the root cause of this issue is unknown; the division will monitor 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: TRANSPORT CHAIR, KNOCKDOWN, STEEL
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: madelyn ruppert ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50896977
• Report Number: 1417592-2026-50782
• Device Sequence Number: 12262334
• Product Code: INM
• UDI-Device Identifier: 00888277329983
• UDI-Public: 00888277329983
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: MDS808200KD
• 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: 10/29/2024
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown