MAUDE Adverse Event Report: FERROSAN MEDICAL DEVICES A/S SURGIFLO¿ HEMOSTATIC MATRIX KIT WITH THROMBIN; Agent, absorbable hemostatic, collagen based

Model Number	2994
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	11/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No lot number is available.
Event or Problem Description
Case 1 of 3: it was reported that gyn surgeon uses surgiflo on the vaginal cuff.He has had 3 ssis since converting from floseal to surgiflo in (b)(6).He thinks surgiflo might be giving his patient's ssis.No surgical delay was reported.Procedure: (b)(6) 2025, event: 11/03/2025 procedure: gyn.Additional information was received on 28.05.2026 stating: what is the name of each procedure? all 3 reports were from total hysterectomies what was the date of each procedure? patient 1: (b)(6) 2025 patient 2: (b)(6) 2025 patient 3: (b)(6) 2025.On what date did each infection occur? patient 1: (b)(6) 2025 patient 2: (b)(6) 2025 patient 3: (b)(6) 2025.How much surgiflo was used during each procedure? one unit of 2994 was used per patient/case.Was surgiflo removed after hemostasis was achieved? surgiflo was not removed after hemostasis on any of the 3 patients.What was the indication for the use of surgiflo? hemostasis after the vaginal cuff was closed.What was the indication for surgery? removal of the uterus and cervix for all 3 patients.What was the medical history of each patient? patient 1: uterine fibroids patient 2: endometriosis patient 3: adenomyosis.What was the treatment for each surgical site infection? open and drain the wound, remove sutures, irrigation and debridement, antibiotics for all 3 patients what are the lot numbers? i was not given the lot numbers as it was reported after the surgical dates.Can specific patient demographics initials / id; age or date of birth; bmi; patient pre-existing medical conditions (i.E.Allergies, history of reactions), all concomitant medications, past medical history, any treatment required for events, dose, frequency, and therapy dates of study drugs be provided? i asked for this information, and the surgeon would not provide it.What is the surgeon's opinion regarding the relationship between the product and the symptoms? the surgeon believes the only protocol that was changed was moving from floseal to surgiflo during the 3 ssis.What is the current condition of each patient? all 3 patients have recovered from their ssis and are healthy in that regard.Additional information were received on 03.06.2026 stating: 1.Was there any surgical contamination or injury during the initial operation? none of the patients had surgical contamination or injury during the initial operation.2.Were cultures performed? if yes, what were the results? no cultures were performed for the 3 patients 3.Please describe the patient manifestations of the reported infection (location, severity, appearance).The physician told me the 3 patients infections presented as vaginal discharge, pelvic pain, cuff tenderness on exam, fever, increased wound drainage.Redness, warmth, and swelling at the incision site.Laparoscopic entry sites.4.Were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? no pre-existing signs of active infection were reported for the 3 patients.5.How much and what type of drainage is present in this wound? (if applicable) i was told there was vaginal discharge and higher than normal wound drainage at the wounds for all 3 patients.

• Brand Name: SURGIFLO¿ HEMOSTATIC MATRIX KIT WITH THROMBIN
• Common Device Name: Agent, absorbable hemostatic, collagen based
• 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: 25515426
• Report Number: 3008478369-2026-00022
• Device Sequence Number: 9993704
• 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
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• 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
• Device Model Number: 2994
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/16/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown