VERISET
Received Jul 21, 2026 · Event occurred Apr 1, 2025
Report 1219930-2026-04628 · MDR key 25895959
Device
Generic name
Agent, Absorbable Hemostatic, Non-collagen Bas
Manufacturer
Covidien SurgicalModel number
HP0505ECatalog number
HP0505E
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Female
- Wound Dehiscence
- Abscess
- Adhesion(s)
- Scar Tissue
Narrative
Additional Manufacturer Narrative
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
Description of Event or Problem
IT WAS REPORTED THAT POSTOPERATIVE COMPLICATIONS OCCURRED FOLLOWING THE USE OF THE HEMOSTATIC PATCH DURING COMPLEX OPEN CESAREAN SECTION PROCEDURE, WHEN THE PRODUCT WAS APPLIED IN AND AROUND THE UTERUS. IMAGE-GUIDED (IR) DRAINAGE WAS PERFORMED, INCLUDING A SURGERY TO DEAL WITH RESULTING SCARRING OR ADHESIONS TO ADDRESS THE COMPLICATIONS AND COMPLETE THE PROCEDURE. THE EVENT WAS REPORTED TO HAVE RESULTED IN OR PROLONGED HOSPITALIZATION BY 1 TO 2 DAYS.