MAUDE Adverse Event Report: Ferrosan Medical Devices A/S SURGIFLO¿ Hemostatic Matrix Kit with Thrombin; Agent, Absorbable Hemostatic, Collagen Based

Model Number	SF2995
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Event or Problem Description
Case 2 of 3: it was reported to the sales rep that following a sling procedure, the surgeon used surgical flow intravaginally, and within one week, three patients returned with abscesses.The issue was reported to have occurred in three instances involving three different patients however, no additional information is available for the other patients.No further information was provided.The device is not being returned.
Additional Manufacturer Narrative
No lot number is available.

• Brand Name: SURGIFLO¿ Hemostatic Matrix Kit with Thrombin
• 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: 50080890
• Report Number: 3008478369-2026-00026
• Device Sequence Number: 13347831
• Product Code: LMF
• UDI-Device Identifier: 15712123000646
• UDI-Public: 15712123000646
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P990004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• 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: SF2995
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/30/2026
• 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