MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PERCLOT; AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Model Number	PCUS003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported during an unspecified surgical procedure perclot was applied.After an unspecified amount of time, on a post operative imaging scan, an infection was found in the area where the perclot was applied.No further information was available at the time of this report.

• Brand Name: PERCLOT
• Common Device Name: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): ARTIVION / CRYOLIFE; 1655 roberts blvd, nw; kennesaw GA 30144
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 22439236
• Report Number: 1416980-2025-03667
• Device Sequence Number: 14253341
• Product Code: LMG
• UDI-Device Identifier: 05413765891366
• UDI-Public: (01)05413765891366(
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P210036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/08/2025

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 Model Number: PCUS003
• Device Catalogue Number: PCUS003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NI.
• Patient Sex: Unknown