MAUDE Adverse Event Report: FERROSAN MEDICAL DEVICES A/S SURGIFLO¿ HEMOSTATIC MATRIX; Agent, absorbable hemostatic, collagen based

Model Number	2991
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	02/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No lot number is available.
Event or Problem Description
It was reported that post-op of a hysterectomy procedure that the patient experienced a surgical site infection.The site was not irrigated and there was no excess bleeding immediately prior to hemostatic agent application.

• Brand Name: SURGIFLO¿ HEMOSTATIC MATRIX
• Common Device Name: Agent, absorbable hemostatic, collagen based
• Manufacturer (Section D): FERROSAN MEDICAL DEVICES A/S; sydmarken 5; soeborg, 2860 ; DA 2860
• Manufacturer Contact: . . ; sydmarken 5; soeborg, 2860 ; DA 2860
• MDR Report Key: 25274701
• Report Number: 3008478369-2026-00017
• Device Sequence Number: 9167676
• Product Code: LMF
• UDI-Device Identifier: 15712123000318
• UDI-Public: 15712123000318
• Combination Product (Y/N): N
• PMA/510(K) Number: P990004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial

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
• Device Model Number: 2991
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown