MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; GOWN,SIRUS,NONRNF,SETINSLV,L,20/CS

Catalog Number	DYNJP2001S
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 customer, three gowns included in a later recall were used during a "total knee arthroplasty" procedure on (b)(6) 2026.The customer reported that the patient developed an "infected knee[s] and required a second surgery on (b)(6) 2026." no additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.No additional information is available.It has been determined that the reported event caused or contributed to serious injury, 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 customer, three gowns included in a later recall were used during a "total knee arthroplasty" procedure on (b)(6) 2026.The customer reported that the patient developed an "infected knee[s] and required a second surgery on (b)(6) 2026.".
Additional Manufacturer Narrative
Update to h6: investigation findings (c).Update to h6: investigation conclusion (d).

• Brand Name: MEDLINE
• Common Device Name: GOWN,SIRUS,NONRNF,SETINSLV,L,20/CS
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: jessica walter ; three lakes drive; northfield, IL 60093
• MDR Report Key: 24327958
• Report Number: 1417592-2026-00119
• Device Sequence Number: 21333414
• Product Code: FYA
• UDI-Device Identifier: 10080196304660
• UDI-Public: 10080196304660
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

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: DYNJP2001S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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: 04/21/2026
• 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