MAUDE Adverse Event Report: FERROSAN MEDICAL DEVICES A/S; SURGIFLO¿ HAEMOSTATIC MATRIX KIT WITH THROMBIN

Device Problem Insufficient Information (3190)

Patient Problem Thromboembolism (2654)

Event Type  Injury  

Event Description

Patient suffered from thrombosis in the brain after the procedure.Customer informed to fill in a medical information request mir patient status.

• Type of Device: SURGIFLO¿ HAEMOSTATIC MATRIX KIT WITH THROMBIN
• Manufacturer (Section D): FERROSAN MEDICAL DEVICES A/S; sydmarken 5; soeborg, 2860 ; DA 2860
• MDR Report Key: 17254851
• MDR Text Key: 318443671
• Report Number: 3008478369-2023-00008
• Device Sequence Number: 1
• Product Code: LMF
• Combination Product (y/n): Y
• 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: 07/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other