MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GOWN,LVL4,OPENBK,THUMBLOOP,OVRHD,BLU,REG

Catalog Number	NONLV410
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that lourdes spd tried this gown and found that it leaked fluid on the arms and abdomen.
Additional Manufacturer Narrative
A complaint was received related to a strikethrough, and the customer reported "fluid soaked through" while "cleaning trays" while leaning against the sink.The samples were inspected and the w.L.Gore elbow lean test was performed on the body and sleeve of the gown; in both tests there was no strikethrough the material, and a review of the contract manufacturer¿s records, manufacturing process, and retained samples found no abnormalities or defects in their production.Based on the results of the investigation, medline was unable to confirm the complaint issue or that the product failed to meet specifications.No root cause was identified in the record.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: GOWN,LVL4,OPENBK,THUMBLOOP,OVRHD,BLU,REG
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: pranay abbu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50806732
• Report Number: 1417592-2026-43945
• Device Sequence Number: 12924916
• Product Code: FYA
• UDI-Device Identifier: 10197344039586
• UDI-Public: 10197344039586
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K213177
• 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): 09/16/2026

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: NONLV410
• Device Lot Number: 49825090001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/20/2026
• 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: 03/12/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown