MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GOWN,ISO,LVL3,SMS,KNITCUFF,HOOKLP,BLU,XL

Catalog Number	NONLV325XL
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2026
Type of Reportable Event	Malfunction

• Brand Name: MEDLINE
• Common Device Name: GOWN,ISO,LVL3,SMS,KNITCUFF,HOOKLP,BLU,XL
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: brooke jantzen ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50926670
• Report Number: 1417592-2026-10454
• Device Sequence Number: 18518908
• Product Code: FYC
• UDI-Device Identifier: 10080196765492
• UDI-Public: 10080196765492
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K160471
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: NONLV325XL
• Device Lot Number: 30526040008
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2026
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown