MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRIO ST; SURGICAL MESH

Catalog Number	5950090
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Fistula (1862)
Date of Event	12/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, patient developed "mesh associated enterocutaneous fistula" and feculent/succus output from abdominal wall almost three years post implant of ventrio st mesh.The patient underwent surgical revision during which there was a takedown of the fistula, a small bowel resection, explantation of the ventrio st mesh and repair of the ventral hernia.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 complication.The instructions-for-use, supplied with the device identifies fistula formation as a possible complication in the adverse reactions section.Review of manufacturing records confirms the product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.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.
Event or Problem Description
As reported per medwatch form (mw5182185): "the patient has developed a mesh-associated enterocutaneous fistula from implanted mesh during ventral hernia repair".As reported per additional information received: as reported, the patient underwent ventral hernia repair with the implant of ventrio st mesh on (b)(6) 2023.On (b)(6) 2025 the patient had feculent/succus output from abdominal wall.The patient underwent ventral hernia repair on (b)(6) 2026 with the fistula takedown, small bowel resection and explant of the ventrio st mesh.

• 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 ; 8005566756
• MDR Report Key: 24496251
• Report Number: 1213643-2026-00270
• Device Sequence Number: 10617409
• Product Code: FTL
• UDI-Device Identifier: 00801741031588
• UDI-Public: (01)00801741031588(11)220606(17)240528(10)HUGT0399
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/17/2026

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 Expiration Date: 05/28/2024
• Device Catalogue Number: 5950090
• Device Lot Number: HUGT0399
• 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: 02/10/2026
• Initial Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2022
• 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 Age: 53 YR
• Patient Sex: Male
• Patient Weight: 89 KG