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

Device Problem Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/10/2021

Event Type  Injury  

Event Description

During emergency surgery for a craniotomy hematoma on a (b)(6) year-old patient, a full unit of surgiflo was used.Postoperative bleeding occurred.The surgeon commented that the patient was hypertensive, and the hematoma was quite large, wherefore he doesn't think the postoperative bleeding was linked to surgiflo.The present event is most likely caused by the clinical condition of the patient, rather than the product, as noted by the surgeon.Note that the instructions for use for surgiflo states: "as with other gelatin hemostatic agents that swell, this device should be used with caution in neurosurgery.Safe and effective use of this device in neurosurgery has not been proven through randomised, controlled studies.".There is no information on patient outcome, post-op consequences or interventions, wherefore follow-up questions have been sent.Although it is unlikely that the event is linked to surgiflo, it cannot be excluded to have a contributary role.(b)(4).

• Type of Device: SURGIFLO® HEMOSTATIC MATRIX KIT WITH THROMBIN
• Manufacturer (Section D): FERROSAN MEDICAL DEVICES A/S; sydmarken 5; soeborg, denmark 2860 ; DA 2860
• MDR Report Key: 12959365
• MDR Text Key: 281902277
• Report Number: 3008478369-2021-00021
• Device Sequence Number: 1
• Product Code: LMF
• UDI-Device Identifier: 25712123000285
• UDI-Public: 25712123000285
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P990004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR