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

Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Eye Irritation (4803)
Type of Reportable Event	Serious Injury
Event or Problem Description
Reported from erd nurse-emergency call: nurse practitioner was splashed with surgiflo hemostatic matrix, in her eye burning sensation, flushed the eye treated it tetricaine, anything else i need to do with it? flushed eye for 15 minutes.Contacted ma and reported to complaints department.Sent msds and ifu to customer via email, told customer to go to the er and follow up with doctor and flush eyes at eye station for 15-20 mins as would with any chemical in the eyes.
Event or Problem Description
Reported from erd nurse-emergency call: nurse practitioner was splashed with surgiflo hemostatic matrix, in her eye burning sensation, flushed the eye treated it tetricaine, anything else i need to do with it? flushed eye for 15 minutes contacted ma and reported to complaints department.Sent msds and ifu to customer via email, told customer to go to the er and follow up with doctor and flush eyes at eye station for 15-20 mins as would with any chemical in the eyes.Follow-up information was received stating: what happen prior the "splash" from surgiflo? please describe, how did it happen? employee is certified surgical tech who was assisting coworker getting ready for another case.They have used the product many times without incident.They reported after mixing the liquid into the dry matrix the 3rd time, one of the syringe's broke causing the mixture to spray into the eyes.They do not remember which syringe broke but they only mixed this 3 times out of the 6 recommended times.Did the nurse received any other treatment? they were sent to the ophthalmologist the next day for assessment after eyes were washed with water and saline.What is the status of the nurse? recovered? per employee report, everything was "ok" and they do not need follow-up.Was there any alleged deficiency with the device that led to the "splash"? there was nothing the employee noted about the product that was out of the norm at the time of the incident.How was the surgiflo matrix prepared? it is unknown how much of the matrix was prepared at the time of the incident.Where they any concomitant products used in the preparation of the surgiflo matrix? there were no other products used with the surgiflo matrix.Additional information was received on 09.04.2024 stating that the device was not surgiflo hemostatic matrix but surgiflo hemostatic matrix kit with thrombin.

• Common Device Name: 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 ; DA 2860
• MDR Report Key: 18884669
• Report Number: 3008478369-2024-00009
• Device Sequence Number: 14225351
• Product Code: LMF
• UDI-Device Identifier: 25712123000285
• UDI-Public: 25712123000285
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,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
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 04/10/2024
• Patient Sequence Number: 1
• Patient Sex: Unknown