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	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to the sales rep that during a craniotomy procedure, the surgeon was using surgiflo when the product became very hard after application.The surgeon stated that the product would normally have a soft, mashed potato-like consistency.No patient consequences were reported.The device is returning.
Event or Problem Description
It was reported to the sales rep that during a craniotomy procedure, the surgeon was using surgiflo when the product became very hard after application.The surgeon stated that the product would normally have a soft, mashed potato-like consistency.No patient consequences were reported.The device is returning.
Additional Manufacturer Narrative
The returned sample with mixed surgiflo has been inspected and evaluated.Based on the available data, the reported issue remains unconfirmed, and the root cause is undetermined.This conclusion is based on the information from user, documentation, and material available at the time of the investigation.Should additional information become available, the assessment may be reconsidered.

• 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: 50427389
• Report Number: 3008478369-2026-00032
• Device Sequence Number: 9178342
• 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
• Type of Report: Initial,Followup

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
• Device Lot Number: 282736
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/25/2026
• Supplement Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown