MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; WC, K3, 16", SB DLA, ELR, 300 LB

Catalog Number	K3166N24E
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that one of the handles that you push the chair has fell fallen off.
Additional Manufacturer Narrative
The customer called and stated that one of the handles that you push the chair has fell fallen off, and the complaint states "no fall or injury." the investigation noted that sample and/or photo was not available; pcn history was reviewed and no product changes were identified that could have contributed to the alleged product failure; quality control inspections records were reviewed with the corrected result of a waived inspection.Investigation results: not confirmed, and no sample or photo of the defective product has been received therefore the issue cannot be confirmed at this time.The cause was documented as "sample required to determine cause"; a formal investigation will be conducted should the sample arrive, or if a detailed photo is provided, 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, K3, 16", SB DLA, ELR, 300 LB
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: abdul khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50898499
• Report Number: 1417592-2026-51003
• Device Sequence Number: 6001559
• Product Code: IOR
• UDI-Device Identifier: 00193489087119
• UDI-Public: 00193489087119
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: K3166N24E
• Device Lot Number: 16421120003
• Was Device Available for Evaluation?: No
• 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: 01/04/2024
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2021
• 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: Female