MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TRANS CHAIR, DLA, SA, 22", 500 LB

Catalog Number	MDS80822B
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the transport chair fell over in the trunk while he was in a van and he noticed the hand brake had broke off.
Additional Manufacturer Narrative
According to the customer, the transport chair fell over in his trunk and the hand brake broke off; the customer stated the strap holding the chair came undone while he took a turn in his van and the chair tipped over, and no one was in the chair at the time of incident.The investigation noted that sample and/or photo/video was not available, medline quality followed up with the customer to try and obtain the necessary information but was unsuccessful, finished good/component trending was performed with no trends identified, and quality control inspections records were reviewed.Investigation results were not confirmed, and the cause was sample required to determine cause.A formal investigation will be conducted should the customer provide medline quality with a photo, video, or a physical 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, DLA, SA, 22", 500 LB
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: william abrams ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50946023
• Report Number: 1417592-2026-54172
• Device Sequence Number: 10429132
• Product Code: INM
• UDI-Device Identifier: 00884389939348
• UDI-Public: 00884389939348
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: MDS80822B
• 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: 02/19/2026
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown