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

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

It was reported that, during an unknown cardiovascular surgery, the product was used on a patient's sternum and the sternum became infected.

Event Description

It was reported that, during an unknown cardiovascular surgery, the product was used on a patient's sternum and the sternum became infected.Follow-up information: which type of bleeding?: "bleeding from sternum" how was the infection handled?: "re-open the chest, debridement and flap formation" did the adverse event required any intervention or longer hospitalization?: "re-open the chest, debridement and flap formation" what is the patient outcome? fully recovered?."the patient discharged" what is the surgeons opinion of the causal relationship between the adverse event and surgiflo?: "the surgeon didn't make it clear".

• Type of Device: SURGIFLO® HEMOSTATIC MATRIX KIT WITH THROMBIN
• Manufacturer (Section D): FERROSAN MEDICAL DEVICES A/S; sydmarken 5; soeborg, 2860 ; DA 2860
• Manufacturer Contact: sydmarken 5; soeborg, 2860
• MDR Report Key: 18118066
• MDR Text Key: 327868229
• Report Number: 3008478369-2023-00015
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• 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