MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC DERMACEA; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number	441002
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Hair on device.

• Brand Name: DERMACEA
• Common Device Name: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 22850773
• Report Number: 22850773
• Device Sequence Number: 15547004
• Product Code: GDY
• UDI-Device Identifier: 20192253048633
• UDI-Public: (01)20192253048633
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/13/2025
• Report Date (Section F): 08/13/2025

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: 441002
• Device Catalogue Number: 441002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/20/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2025
• 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: 08/13/2025