FLOSEAL
Received Nov 19, 2025
Report 1416980-2025-05756 · MDR key 23600250
Device
Generic name
Agent, Absorbable Hemostatic, Collagen Based
Manufacturer
Baxter Healthcare CorporationModel number
NICatalog number
NI
Lot number
NI
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Seroma
- Seroma
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED A PATIENT DEVELOPED A SEROMA WHEREIN FLOSEAL WAS APPLIED. DURING AN UNSPECIFIED FISTULA OR GRAFT SURGERY FLOSEAL WAS APPLIED TO TREAT OOZING SURGICAL BLEEDING. EXCESS FLOSEAL WAS IRRIGATED AWAY; HOWEVER, SOME CLUMPS THAT WERE ATTACHED TO THE AREA, WERE NOT REMOVED. AFTER AN UNSPECIFIED AMOUNT OF TIME POST-SURGICAL, A SEROMA FORMATION WAS OBSERVED AT THE INCISION SITE WHERE FLOSEAL WAS USED. THE PATIENT UNDERWENT AN ASPIRATION AND SCLEROSANT IN INTERVENTIONAL RADIOLOGY. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: H10. H11: SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative
CORRECTION: C, G1, AND G4. H11: SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.