MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; WC,K1,18",SB DLA,SA, 300 LB

Catalog Number	K1186N22S
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Wheelchair_not locking_folding mechanism.
Additional Manufacturer Narrative
The customer stated that the unit was working well until they folded it to place it into the car and when they took it back out the unit was not folding back out, and customer had several people try to open it without success.Medline received the sample of a wheelchair in used condition; slight wear was observed on the wheels and seat upholstery, the legrest were not returned, and the folding mechanism was tested by unfolding and folding the unit.The folding mechanism operated smoothly with ease, no bends were observed in the slide tubes to restrict it from opening and closing, the wheels rolled freely, and the wheel locks engaged and secured the wheels properly.This customer complaint has been not confirmed; no other physical damage was observed, and all other components appear to be as designed.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,K1,18",SB DLA,SA, 300 LB
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: ayan asim ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50899007
• Report Number: 1417592-2026-51085
• Device Sequence Number: 5853077
• Product Code: IOR
• UDI-Device Identifier: 00193489001061
• UDI-Public: 00193489001061
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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: K1186N22S
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/14/2025
• 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: 10/02/2025
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown