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

Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Cardiovascular Dysfunction/Insufficiency (4445); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to the sales rep that during a craniotomy procedure that the doctor put surgiflo in a cavernoma and the patient started experiencing bradycardia.Once surgiflo was removed the patient returned back to baseline.Unknown as to how the procedure was completed.There were no long term adverse consequences for the patient.An allergic reaction cannot be ruled out based on the available information.The surgeon's opinion to the cause of the bradycardia was stated as "surgiflo".
Event or Problem Description
It was reported to the sales rep that during a craniotomy procedure that the doctor put surgiflo in a cavernoma and the patient started experiencing bradycardia.Once surgiflo was removed the patient returned back to baseline.Unknown as to how the procedure was completed.There were no long term adverse consequences for the patient.An allergic reaction cannot be ruled out based on the available information.The surgeon's opinion to the cause of the bradycardia was stated as "surgiflo".Follow-up information: surgiflo was used on-label.Follow-ip imformation no.2: sales representative reported that there was brain swelling caused from the surgiflo 2994.
Event or Problem Description
It was reported to the sales rep that during a craniotomy procedure that the doctor put surgiflo in a cavernoma and the patient started experiencing bradycardia.Once surgiflo was removed the patient returned back to baseline.Unknown as to how the procedure was completed.There were no long term adverse consequences for the patient.An allergic reaction cannot be ruled out based on the available information.The surgeon's opinion to the cause of the bradycardia was stated as "surgiflo".Follow-up information: surgiflo was used on-label.

• Common Device Name: SURGIFLO® HEMOSTATIC MATRIX KIT WITH THROMBIN
• Manufacturer (Section D): FERROSAN MEDICAL DEVICES A/S; sydmarken 5; soeborg, 2860 ; DA 2860
• MDR Report Key: 18019773
• Report Number: 3008478369-2023-00012
• Device Sequence Number: 7702569
• Product Code: LMF
• UDI-Device Identifier: 15712123000288
• UDI-Public: 15712123000288
• Combination Product (Y/N): Y
• PMA/510(K) Number: P990004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/27/2023
• Supplement Report FDA Received Date: 11/28/2023; 12/19/2023
• Patient Sequence Number: 1
• Patient Sex: Unknown