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)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the account contact to sales rep that during a crania procedure, an expired device was used during the case.No additional information.No product is available for evaluation.Additional information was received 31.08.2026 stating: was the use of expired product intentionally? no.Was the expiry date clear readable on the device? unknown.Why was a expired product used? i was told it was a complete accident by the or staff.What is the lot number? unknown.What was the date of the procedure? unknown.What was the indication for using the product? i was previously told it was for hemostasis.Was there any patient consequence? unknown.Can specific patient demographics initials / id; age or date of birth; bmi; gender; patient pre-existing medical conditions (i.E.Allergies, history of reactions), all concomitant medications, past medical history, any treatment required for events, dose, frequency, and therapy dates of study drugs be provided? unknown.What is the current condition of the patient? unknown.
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: 50750158
• Report Number: 3008478369-2026-00034
• Device Sequence Number: 10367689
• Product Code: LMF
• UDI-Device Identifier: 15712123000288
• UDI-Public: 15712123000288
• 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

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/14/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown