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

Device Problem Insufficient Information (3190)

Patient Problem Swelling/ Edema (4577)

Event Type  Injury  

Event Description

Case 1/2: a hcp has been trialing surgiflo with thrombin in acdf cases.The hcp has completed 12 thus far.In two patients from the prior week, the patients have suffered swelling which the hcp deems abnormal.The only change to the hcp's usual technique has been to switch from floseal to surgiflo.

• Type of Device: SURGIFLO HAEMOSTATIC MATRIX KIT WITH THROMBIN
• Manufacturer (Section D): FERROSAN MEDICAL DEVICES A/S; sydmarken 5; soeborg, denmark 2860 ; DA 2860
• MDR Report Key: 15657178
• MDR Text Key: 302249661
• Report Number: 3008478369-2022-00011
• 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
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1