MAUDE Adverse Event Report: CARDINAL HEALTH, INC. KENDALL; DRESSING, WOUND, OCCLUSIVE

Model Number	55535
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Package found intact with a black substance on the inside and on the foam.

• Brand Name: KENDALL
• Common Device Name: DRESSING, WOUND, OCCLUSIVE
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 24003282
• Report Number: 24003282
• Device Sequence Number: 21465438
• Product Code: NAD
• UDI-Device Identifier: 10884521020900
• UDI-Public: (01)10884521020900
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2025
• Report Date (Section F): 12/11/2025

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 Model Number: 55535
• Device Catalogue Number: 55535
• Device Lot Number: 23C093262
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/08/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2026
• 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
• Date Report Sent to FDA: 12/11/2025