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	Hematoma (1884)
Date of Event	02/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that perclot was used during two penile implant surgeries where post-operatively, it was reported that both patients developed ¿massive haematomas¿ and had a significant drain output.One patient needed to keep the drain in for five days.During the use of the perclot, there was normal bleeding for these cases and bleeding was stopped and dried up the area as expected by the doctor.No additional information is available.
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.

• 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: 21704113
• Report Number: 1416980-2025-01476
• Device Sequence Number: 4656640
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/26/2025

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: 02/27/2025
• Initial Report FDA Received Date: 03/26/2025
• 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: COTOPLAST IMPLANT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown