MAUDE Adverse Event Report: Medline Industries, LP GUARDIAN; SHOWER COMMODE WC, ALUMINUM, 275 LB

Catalog Number	G1-503WCPX1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "customer has a shower chair and one of the front wheels the bearings are seized up and because of that the wheels will not turn.".
Additional Manufacturer Narrative
The customer reported that "one of the front wheels the bearings are seized up and because of that the wheels will not turn." a photo depicting the defect was provided and only a visual review of the defect could be conducted; the product appeared to be in used condition due to dirt and grime buildup on the caster assembly and frame tubing.Investigation results were not confirmed, and no visible physical defects appeared that would indicate a failure in the unit¿s front caster bearing; therefore, the issue could not be identified based on the photos provided.A physical sample was not provided, proof of purchase and a video had not been received, no trends were identified for the specified material number and corresponding defect type, 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: GUARDIAN
• Common Device Name: SHOWER COMMODE WC, ALUMINUM, 275 LB
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: diana arizmendi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50898766
• Report Number: 1417592-2026-51037
• Device Sequence Number: 17599679
• Product Code: INM
• UDI-Device Identifier: 00193489028754
• UDI-Public: 00193489028754
• 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): 09/24/2026

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: G1-503WCPX1
• Device Lot Number: 16424060002
• 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: 02/11/2026
• Initial Report FDA Received Date: 09/25/2026
• 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