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	Inflammation (1932)
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 at least three patients developed ¿an unusual inflammatory response¿ during unspecified thyroid and parathyroid surgical procedures with perclot.Furthermore, between post operative day two and four each patient developed ¿redness around the incision¿ which required unspecified ¿allergy medication¿ to treat the ¿potential allergic reactions.¿ 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: 23634171
• Report Number: 1416980-2025-05805
• Device Sequence Number: 18464117
• Product Code: LMG
• UDI-Device Identifier: 05413765891366
• UDI-Public: (01)05413765891366
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 11/24/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 11/24/2025
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NI.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown