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

Catalog Number	MDS808200KD
Medical Device Problem Codes	Mechanical Problem (1384); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "transport chair left handle will not stay up resulting in upholstery being torn.".
Additional Manufacturer Narrative
The customer stated that the left handle will not attach properly onto the unit, resulting in the back upholstery being torn; no injuries were reported on call.After reviewing the photo and video provided by the customer, it was discovered that despite multiple attempts by the customer to lock the push handle¿s locking pin into the receiving hole, it did not appear to lock into place; a physical sample was not provided.The investigation results were confirmed, and the left side of the back upholstery appears to be significantly ripped.The root cause of this issue is unknown; no trends were identified for the specified material number and its corresponding defect type, and the division will monitor this issue 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: rizwan shaik ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50869361
• Report Number: 1417592-2026-48833
• Device Sequence Number: 9314590
• Product Code: INM
• UDI-Device Identifier: 00888277329983
• UDI-Public: 00888277329983
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 09/22/2026

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: 12/29/2025
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2023
• 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