MAUDE Adverse Event Report: Medline Industries, LP PRIVATE LABELED FOR CUSTOMER; DBD-WHEELCHAIR, WALGREENS, K3

Catalog Number	WRX400195
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "about 2 weeks ago the rubber on the wheel came off" and "this new one does not function as well.".
Additional Manufacturer Narrative
The customer reported the rubber on the wheel came off and stated, "this new one does not function as well." medline quality has yet to receive the requested information from the customer, and follow up to obtain the necessary information to process the complaint was unsuccessful; finished good/component trending was performed and no trends were identified for the specified material number and its corresponding defect type.The complaint could not be confirmed, as a lot number or serial number, physical sample, photo, or video were not available for evaluation.Sample required to determine cause; 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: PRIVATE LABELED FOR CUSTOMER
• Common Device Name: DBD-WHEELCHAIR, WALGREENS, K3
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: shivani gheewala ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50888077
• Report Number: 1417592-2026-50375
• Device Sequence Number: 21279959
• Product Code: IOR
• UDI-Device Identifier: 00311917135373
• UDI-Public: 00311917135373
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K990463
• 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: WRX400195
• 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: 03/17/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown