MAUDE Adverse Event Report: FERROSAN MEDICAL DEVICES A/S SURGIFLO¿ HEMOSTATIC MATRIX KIT 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)
Date of Event	05/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the sales rep that the product was expired by one day and was still used.It was used may 1 but expired on april 30.There were no patient consequences reported.
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: 22140243
• Report Number: 3008478369-2025-00022
• Device Sequence Number: 12796925
• 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?: No
• Is this a Product Problem Report?: No
• Device Model Number: 2994
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/04/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown