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	Wound Dehiscence (1154)
Type of Reportable Event	Serious Injury
Event or Problem Description
The case was received from ethicon's complaint team.During follow-up surgiflo was mentioned as a device used during initial surgery and the case is therefore forwarded to ferrosan medical devices a/s.The initial case handled by ethicon (ethicon device) was received 03.01.2024.Follow-up information implicating surgiflo was received 19.01.2024.Initial information: sales rep reported that a patient had to come back to have vaginal cusp today on (b)(6) 2024 reclosed due to it dehiscing.Rep will send rest of product within remaining associated lot number for analysis.Follow-up information: it was reported by the sales rep that post op of an open hysterectomy, vaginal cuff dehiscence.The patient came back for reoperation on (b)(6) 2024.2994 x 2.At the time of the call patient harm was unknown.The surgeon is wondering if the use of the double 2994 is what led to the dehiscence.

• 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: 18649141
• Report Number: 3008478369-2024-00005
• Device Sequence Number: 7187165
• Product Code: LMF
• UDI-Device Identifier: 15712123000288
• UDI-Public: 15712123000288
• 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: 02/06/2024
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown