MAUDE Adverse Event Report: FERROSAN MEDICAL DEVICES A/S; SURGIFLO TM HAEMOSTATIC MATRIX

Device Problem Insufficient Information (3190)

Patient Problem Embolism/Embolus (4438)

Event Type  Death  

Event Description

The surgical instrumentalist of the cardiovascular surgery program comments that after the use of surgiflo on the suture line that was performed in a vental, after a few minutes the extracorporeal circulation machine became clogged.The patient died the next day.

• Type of Device: SURGIFLO TM HAEMOSTATIC MATRIX
• Manufacturer (Section D): FERROSAN MEDICAL DEVICES A/S; sydmarken 5; soeborg, denmark 2860 ; DA 2860
• MDR Report Key: 15092459
• MDR Text Key: 296462678
• Report Number: 3008478369-2022-00007
• Device Sequence Number: 1
• Product Code: LMF
• Combination Product (y/n): N
• PMA/PMN Number: P990004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death