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

Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Calcium Deposits/Calcification (1758)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the sales rep, that around two to three months post-op for a prostatectomy, that there has been an unknown amount of patients that have had calcification around the site where they used the surgiflo.They have been using the product 2991 to fill in the dead space after they bring down the bladder neck.They have not had this issue before and think the surgiflo could be causing it.They are currently using surgiflo with saline and not thrombin.No patient consequence.Device is not available for return.

• Common Device Name: SURGIFLO¿ HEMOSTATIC MATRIX
• Manufacturer (Section D): FERROSAN MEDICAL DEVICES A/S; sydmarken 5; soeborg, 2860 ; DA 2860
• MDR Report Key: 19989723
• Report Number: 3008478369-2024-00029
• Device Sequence Number: 6964225
• Product Code: LMF
• UDI-Device Identifier: 15712123000318
• UDI-Public: 15712123000318
• Combination Product (Y/N): N
• 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: 08/15/2024
• Patient Sequence Number: 1
• Patient Sex: Unknown