MAUDE Adverse Event Report: FERROSAN MEDICAL DEVICES A/S; SURGIFLO¿ HEMOSTATIC MATRIX KIT WITH THROMBIN

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to the sales rep by the or manager reported on behalf of the surgeon and his pa igor.That they are frustrated with surgiflo.They prefer floseal over surgiflo.They believe floseal is much more granular and sticks/adheres to the tissues of the bleeding site.Where they have noticed that surgiflo isn't adhereing as well as floseal even after they wait 3 minutes.They are still noticing bleeding at the bleeding site.There have been two patients that have come back with hematomas which were able to be treated with medication but igor the pa believes this is due to the change to surgiflo over floseal.No patient consequence was reported.No device is available for evaluation.Follow-up information was received stating: - was surgiflo removed after hemostasis was achieved or left: "yes, surgiflo was removed" - how much surgiflo was used? "1 each of 2994 (8ml)" - how was the hematoma/s treated? "medication - no additional information provided.".

• Common Device Name: SURGIFLO¿ HEMOSTATIC MATRIX KIT WITH THROMBIN
• 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: 20705818
• Report Number: 3008478369-2024-00044
• Device Sequence Number: 13237421
• Product Code: LMF
• UDI-Device Identifier: 15712123000288
• UDI-Public: 15712123000288
• Combination Product (Y/N): Y
• 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
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/18/2024
• Patient Sequence Number: 1
• Patient Sex: Unknown