MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; GLOVE,EXAM,STERILE,PF,NITRILE,PR,XC,S

Catalog Number	MDS198414
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2025
Type of Reportable Event	Malfunction

• Brand Name: MEDLINE
• Common Device Name: GLOVE,EXAM,STERILE,PF,NITRILE,PR,XC,S
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: hnin phyu ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25882438
• Report Number: 1417592-2026-06962
• Device Sequence Number: 21473083
• Product Code: LZA
• UDI-Device Identifier: 10888277307070
• UDI-Public: 10888277307070
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K160467
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/20/2026

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: MDS198414
• Device Lot Number: PAN100062079
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 07/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2000
• 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