MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; WC, XW, 22", RDLA, SA, 500 LB

Catalog Number	KX228V21S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after unboxing unit noticed the l rear wheel spoke is broken by the rear axle.
Additional Manufacturer Narrative
It was reported that broken rear wheel and stated that after unboxing the unit the left rear wheel spoke was broken by the rear axle; no shipping damage was indicated.Medline received one wheelchair in new condition, reviewed the customer photos, and performed functional/visual inspection; the seat and back were intact with no rips, punctures or fractures, the right rear wheel hub cap was fractured, and the left rear wheel had multiple spokes fractured off at the hub.The same damage was seen in the pictures as was physically present, and the customer complaint was confirmed.Cause codes documented were mfg: material composition and mishandling: by mfg.Or can't determine; no product changes were identified that could have contributed to the alleged product failure, and the division will monitor through 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, XW, 22", RDLA, SA, 500 LB
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkat gaanuthula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50897304
• Report Number: 1417592-2026-50838
• Device Sequence Number: 20340106
• Product Code: IOR
• UDI-Device Identifier: 00193489179920
• UDI-Public: 00193489179920
• 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: KX228V21S
• Device Lot Number: 16422120001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/17/2023
• 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: 10/04/2023
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Male