MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; GOWN,ECLIPSE,NONRNF,XL,ST,30/CS

Catalog Number	DYNJP2002
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	12/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility, medline gowns were recalled and 1 xl gown had been used during a total knee arthroplasty procedure prior to the facility becoming aware of the recall.The procedure was initially performed on (b)(6) 2025.The patient subsequently required a second surgery on (b)(6) 2026, due to an infected knee.The facility cannot confirm or deny whether the infection was a result from the gown.No additional information is available at this time.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the facility, medline gowns were recalled and 1 xl gown had been used during a total knee arthroplasty procedure prior to the facility becoming aware of the recall.The procedure was initially performed on (b)(6) 2025.The patient subsequently required a second surgery on (b)(6) 2026, due to an infected knee.
Additional Manufacturer Narrative
Updated h6: investigation findings (c).Updated h6: investigation conclusions (d).Updated h7: if remedial action initiated, check type.Updated h9: if action reported to fda under 21 usc 360i(g), list correction/removal reporting number.

• Brand Name: MEDLINE
• Common Device Name: GOWN,ECLIPSE,NONRNF,XL,ST,30/CS
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alyssa reasner ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24327714
• Report Number: 1417592-2026-00117
• Device Sequence Number: 9542141
• Product Code: FYA
• UDI-Device Identifier: 10080196073658
• UDI-Public: 10080196073658
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K190950
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJP2002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: R-26-003
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown