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

Device Problem Insufficient Information (3190)

Patient Problem Swelling/ Edema (4577)

Event Type  Injury  

Event Description

Sales rep reported that there was brain swelling caused from the surgiflo 2994.

Event Description

Sales rep reported that there was brain swelling caused from the surgiflo 2994.This case is nullified (cancelled) as it is a doublicate if previously reported adverse event.Mfr report #: 3008478369-2023-00012.

• Type of Device: SURGIFLO® HEMOSTATIC MATRIX KIT WITH THROMBIN
• Manufacturer (Section D): FERROSAN MEDICAL DEVICES A/S; sydmarken 5; soeborg, 2860 ; DA 2860
• MDR Report Key: 18019807
• MDR Text Key: 326679018
• Report Number: 3008478369-2023-00013
• Device Sequence Number: 1
• Product Code: LMF
• UDI-Device Identifier: 15712123000288
• UDI-Public: 15712123000288
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: No
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1