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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FERROSAN MEDICAL DEVICES A/S; SURGIFLO® HEMOSTATIC MATRIX KIT WITH THROMBIN
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FERROSAN MEDICAL DEVICES A/S; SURGIFLO® HEMOSTATIC MATRIX KIT WITH THROMBIN Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Hypersensitivity/Allergic reaction (1907); Cardiovascular Insufficiency (4445); Swelling/ Edema (4577)
Event Type  Injury  
Event 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 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 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.
 
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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 Key18019773
MDR Text Key326678321
Report Number3008478369-2023-00012
Device Sequence Number1
Product Code LMF
UDI-Device Identifier15712123000288
UDI-Public15712123000288
Combination Product (y/n)Y
PMA/PMN Number
P990004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial,Followup,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Is the Reporter a Health Professional? No
Patient Sequence Number1
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