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

Lot Number	281798
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury

• Brand Name: SURGIFLO¿ Haemostatic 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: 50174071
• Report Number: 3008478369-2026-00030
• Device Sequence Number: 18613648
• 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 Lot Number: 281798
• 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: 08/07/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown