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

Catalog Number	K1186N22S
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	10/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the foam on the arm rests is rubbing off and causing them to be scratchy on the patient¿s arms.".
Additional Manufacturer Narrative
The customer reported that the foam on the arm rests is rubbing off and causing them to be scratchy on the patient¿s arms.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, the armrest pad vinyl upholstery and the armrest pad plastic bracket appeared to be intact, and the foam inside of the armrest pad was not visible in the photo.The investigation results were not confirmed, and the issue could not be confirmed based on the photo provided.A physical sample was not provided, and the cause was updated to unconfirmed defect - sample required to determine cause; 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,K1,18",SB DLA,SA, 300 LB
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL
• Manufacturer Contact: rizwan shaik ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50885293
• Report Number: 1417592-2026-50165
• Device Sequence Number: 21279929
• Product Code: IOR
• UDI-Device Identifier: 00193489001061
• UDI-Public: 00193489001061
• 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: K1186N22S
• 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: 10/21/2024
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2024
• 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