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

Catalog Number	MDS808210ARE
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "left-side cable broke.".
Additional Manufacturer Narrative
The customer reported a damaged brake cable and that the "leftside cable broke and needs to be replaced." a physical sample was not provided; a photo depicting the defect was provided and only a visual review of the defect could be conducted.Investigation results were confirmed, and after reviewing the photo, it was found that the left side brake cable appears to have fractured away from the cable receiver on the brake handle assembly.Based on the photo evidence and the incident report, 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 continue to 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,ALUM,12 WHL, 19" 300 LB, RED
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: pranayreddy alluri ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50951607
• Report Number: 1417592-2026-55002
• Device Sequence Number: 13167879
• Product Code: INM
• UDI-Device Identifier: 40884389150819
• UDI-Public: 40884389150819
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 09/30/2026

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: MDS808210ARE
• 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: 07/17/2025
• 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