MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; WC,K4,22",DLA,SA, 350 LB

Catalog Number	MDS806570
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the gold cover on the screw is missing where the height of the handles are fastened in the hole so that the left handle moves when i push her in the wheelchair.".
Additional Manufacturer Narrative
The customer stated "left handle is loose" and "it is missing knob to adjust height of it"; the customer also stated that the gold cover on the screw is missing where the height of the handles are fastened in the hole so that the left handle moves when pushed in the wheelchair.A physical sample was not provided; a photo depicting the defect was provided and only a visual review of the defect could be conducted, and a functional or dimensional inspection could not be executed via a photo.Investigation results were not confirmed; the complaint file lists the defect as missing parts/components/shortage - push button and the updated cause code as defect confirmed: supplier mfg./error asia (medline branded), mfg: assembly/human error.A replacement push button was issued, the replacement knob did not resolve the issue, a full replacement was issued, and the division will monitor 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: WC,K4,22",DLA,SA, 350 LB
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: shivani gheewala ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50884188
• Report Number: 1417592-2026-49955
• Device Sequence Number: 10704817
• Product Code: IOR
• UDI-Device Identifier: 00080196739557
• UDI-Public: 00080196739557
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: MDS806570
• 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: 03/01/2023
• Initial Report FDA Received Date: 09/24/2026
• 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