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

Catalog Number	WRX490530V2
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the four knob was broken when i pulled it out the box brand new, knob came defective.".
Additional Manufacturer Narrative
The customer reported that after unboxing the unit, one of the height adjustment knobs for the handles was broken, and the product was received this way.A physical sample was not provided; a photo depicting the defect was provided and only a visual review of the defect could be conducted.The investigation results were confirmed, and after reviewing the photo, it was discovered that the adjustment knob appears fractured.The product appears to be in new condition; therefore, this issue is most likely due to shipping damage, and no product changes were identified that could have contributed to the alleged product failure.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: lauren glaeser ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50867413
• Report Number: 1417592-2026-48583
• Device Sequence Number: 18810022
• Product Code: ITJ
• UDI-Device Identifier: 00311917203065
• UDI-Public: 00311917203065
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/21/2026

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: WRX490530V2
• Device Lot Number: 88523090001
• 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: 03/17/2025
• Initial Report FDA Received Date: 09/23/2026
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown