MAUDE Adverse Event Report: SURGIFLO HAEMOSTATIC MATRIX WITH THROMBIN; Agent, absorbable hemostatic, collagen based

Model Number	2994
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No lot number is available.
Event or Problem Description
Event description: the sales representative reported that during an open reduction internal fixation (orif) procedure surgiflo was used, some of the patient's blood was salvaged and processed through a cell saver, and the processed blood was returned to the patient.The device is not available for return.Note in file: as per rep: "the surgical team was concerned that the blood may be contaminated with the particles of surgiflo cell saver.".

• Brand Name: SURGIFLO HAEMOSTATIC MATRIX WITH THROMBIN
• Common Device Name: Agent, absorbable hemostatic, collagen based
• Manufacturer Contact: sydmarken 5; soeborg, 2860
• MDR Report Key: 23630787
• Report Number: 3008478369-2025-00040
• Device Sequence Number: 9317835
• Product Code: LMF
• UDI-Device Identifier: 25712123000285
• UDI-Public: 25712123000285
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• 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
• Report Date (Section B): 11/21/2025

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: 2994
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown