MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TRANSLATOR,DLA,SA, 8" WHLS, 18", 300 LB

Catalog Number	MDS868BTRB
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Fall (1848)
Date of Event	11/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "translator has fractured at the weld left side when sitting in it.".
Additional Manufacturer Narrative
The customer reported that the translator has fractured at the weld left side when sitting in it; fall did occur and some brusing but no medical attention was needed.Upon receiving the unit, the folding mechanism opened and closed properly, the right brake did not function properly and the right rear wheel rotated when the brake was engaged, the left brake did function properly, the backrest bar secured properly into both holsters, the seat upholstery was intact, and all four wheels were severely worn and dirty.Upon investigation, the right rear leg was fractured under the weld with the rear seat support bar, and the thickness of the rear leg at the fracture site measured 1.4mm, which is within specifications.The customer complaint has been confirmed; cause was cannot determine cause w/received sample, and no trends were identified for the specified material number and its corresponding defect type.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: TRANSLATOR,DLA,SA, 8" WHLS, 18", 300 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: 50889534
• Report Number: 1417592-2026-50528
• Device Sequence Number: 10663926
• Product Code: INM
• UDI-Device Identifier: 00193489180605
• UDI-Public: 00193489180605
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: MDS868BTRB
• Device Lot Number: 885XX050001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/16/2025
• 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: 12/10/2025
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 79 YR
• Patient Sex: Male
• Patient Weight: 250 LB