MAUDE Adverse Event Report: Davol Inc., Sub. C.R. Bard, Inc. -1213643 Ventrio ST; Surgical Mesh

Catalog Number	5950040
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	10/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient underwent an umbilical hernia repair procedure on (b)(6) 2025 with the implant of a ventrio st mesh.About 1 week later, the patient developed an infection on the right side of her incision.An mri was performed and she was provided antibiotics.The following week, the patient continued with the symptoms of infection, she consulted with a new surgeon who ordered another mri of her abdomen and determined she was still infected and the mesh needed to be removed.The patient was injected with botox to help loosen the muscles around her abdominal wall before having the mesh removed.As reported, on (b)(6) 2026 patient underwent removal of the ventrio st mesh.Contact alleges the mesh was infected.No further issues have presented since the removal of the mesh other than some tenderness with bending but no further treatment or recommendations have been provided.
Additional Manufacturer Narrative
As reported, the patient developed an infection one week post implant of ventrio st mesh and subsequently the mesh was explanted due to the infection.Based on the information provided, no conclusions can be made as to the degree to which the implant may have caused or contributed to the patient's postoperative infection.Infection is listed in the adverse reactions section of the instructions-for-use supplied with the device as a possible complication.Regarding infection the warning section of the ifu states, "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the mesh".A review of manufacturing records was performed and found that the device was manufactured to specification.To date, this is the only reported complaint for this lot of 188 units released for distribution.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: Ventrio ST
• Common Device Name: Surgical Mesh
• Manufacturer (Section D): Davol Inc., Sub. C.R. Bard, Inc. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): Bard Shannon Limited -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; +1(800)556-6756
• MDR Report Key: 50021659
• Report Number: 1213643-2026-00942
• Device Sequence Number: 18792580
• Product Code: FTL
• UDI-Device Identifier: 00801741031533
• UDI-Public: (01)00801741031533(11)250314(17)270228(10)HUKQ0778
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/10/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 5950040
• Device Lot Number: HUKQ0778
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female