MAUDE Adverse Event Report: Medline Industries, LP PRIVATE LABELED FOR CUSTOMER; DBD-ROLLATOR, KNOCK DOWN, WGNS

Catalog Number	WRX490530
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the push button on the walker "broke off".
Additional Manufacturer Narrative
The customer contacted medline regarding their rollator and stated "the push button on the rollator broke off"; the complaint transcript states the product was being used under "normal use" and the customer is not sure what caused the issue.The customer provided a photo of the backrest and not the full unit, and a physical sample was not provided; only a visual review of the defect can be conducted, and after reviewing the photo it was discovered that the larger push button used to unlock the backrest on the left side has fractured off.Investigation results: confirmed.Given the evidence provided in the photo the root cause of this issue is unknown; no product changes were identified that could've contributed to this product failure, the inspection records reviewed all passed inspection, corrective/preventive action taken/ecn/pcn¿s: no, and additional recommendations: none.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: PRIVATE LABELED FOR CUSTOMER
• Common Device Name: DBD-ROLLATOR, KNOCK DOWN, WGNS
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: narendra nambula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50889361
• Report Number: 1417592-2026-50516
• Device Sequence Number: 13202150
• Product Code: IKX
• UDI-Device Identifier: 00311917203065
• UDI-Public: 00311917203065
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: WRX490530
• Device Lot Number: 88522020001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/13/2023
• 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: 11/03/2023
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (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