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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
Event description: sales rep reported from the surgeon that after a presentation with a follow up question and said she had a patient she performed lap ovarian surgery on and used surgiflo 2994 with lap applicator and patient had significant post op pain and has been readmitted twice with otherwise normal work up.Surgeon wanted to know if there are reports of inflammatory or allergic type reactions to surgiflo.Rep provided product ifu and discussed known adverse events and disclosed that i would file this product complaint.Follow-up information: a response was received from the sales rep stating that no further information will be provided for this complaint.In addition no product is available to be returned for evaluation.

• Common Device Name: SURGIFLO® HEMOSTATIC MATRIX KIT WITH THROMBIN
• Manufacturer (Section D): FERROSAN MEDICAL DEVICES A/S; sydmarken 5; soeborg, ; DA
• MDR Report Key: 18795606
• Report Number: 3008478369-2024-00008
• Device Sequence Number: 20618832
• 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

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/28/2024
• Patient Sequence Number: 1
• Patient Sex: Unknown