MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GOWN,ORBIS,LVL 3,XLARGE,ST,24/CS

Catalog Number	DYNJP2367P
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that physician experienced strikethrough from fluid on surgical gown twice in two different cases.Strikethrough was somewhere on sleeve of gowns.
Additional Manufacturer Narrative
The reported failure was strikethrough from fluid on surgical gown twice in two different cases, somewhere on sleeve of gowns.No sample was returned for the investigation, and complaint history and nonconformance trending for this product and this customer for the past six months were reviewed.The reported issue was not confirmed.The gown is a level 3 gown; it is fluid resistant but will not prevent strikethrough, and this was identified as a customer knowledge issue.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,ORBIS,LVL 3,XLARGE,ST,24/CS
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: rizwan shaik ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50524513
• Report Number: 1417592-2026-28490
• Device Sequence Number: 9865787
• Product Code: FYA
• UDI-Device Identifier: 20193489083375
• UDI-Public: 20193489083375
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K220333
• 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): 09/14/2023

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: DYNJP2367P
• 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: 09/14/2023
• Initial Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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