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

Device Problem Insufficient Information (3190)

Patient Problem Abscess (1690)

Event Type  Injury  

Event Description

A sales rep was in surgery at a neurosurgery clinic.It was a lumbar spine operation with viper prime system and some hemostatic product was needed.It was stated that they re-operated at least one case and found some cloudy liquid but no infection.All cases were anterior cervical cases and it is very rare to have infection after those operations.

• Type of Device: SURGIFLOTM HAEMOSTATIC MATRIX KIT WITH THROMBIN
• Manufacturer (Section D): FERROSAN MEDICAL DEVICES A/S; sydmarken 5; soeborg, denmark 2860 ; DA 2860
• MDR Report Key: 15787196
• MDR Text Key: 303552998
• Report Number: 3008478369-2022-00013
• 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: 11/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1