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

Catalog Number	5954450
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	11/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, several years post implant of the ventralight st mesh, the patient underwent a procedure (colectomy) unrelated to the implant.During this procedure the ventralight st mesh was cut by the surgeon and the surgeon elected to leave the partially cut ventralight st mesh in place.Following the colectomy the patient developed wound dehiscence and the ventralight st mesh was subsequently removed.The complainant states that no inherent issue was believed to exist with the ventralight st mesh, and that the complications were felt to have been caused by the mesh being cut during the colectomy procedure and left in place.Based on the event as reported there was no issue with the ventralight st mesh as provided and used by the surgeon to repair the patient¿s umbilical hernia.The reported event appears to have resulted from surgical actions taken during the unrelated procedure performed several years after the initial implant.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, the patient underwent an umbilical hernia repair procedure with placement of a ventralight st mesh and a right inguinal hernia repair with a 3dmax mesh on (b)(6) 2020.On (b)(6) 2024 the patient underwent a colectomy due to chronic diverticulosis.During the colectomy, the previously placed ventralight st mesh was cut through by the surgeon, and although the colectomy was completed, the partially cut mesh was elected to be left in place.Following this surgery, a small open area on the patient¿s abdomen developed, which progressively enlarged into a significant wound requiring wound care for approximately seven months, and the mesh was noted to be protruding through the skin.The ventralight st mesh was subsequently removed on (b)(6) 2024, and a non-bd mesh was implanted to repair a newly developed hernia.The complainant states that no inherent issue was believed to exist with the original ventralight st mesh, and that the complications were felt to have been caused by the mesh being cut during the colectomy procedure and left in place.Note, the 3dmax mesh placed for repair of the right inguinal hernia remains implanted.

• Brand Name: VENTRALIGHT ST MESH
• 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: 24517863
• Report Number: 1213643-2026-00289
• Device Sequence Number: 8439325
• Product Code: FTL
• UDI-Device Identifier: 00801741031618
• UDI-Public: (01)00801741031618(17)220128(10)HUDZ2116
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/18/2026

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: 01/28/2022
• Device Catalogue Number: 5954450
• Device Lot Number: HUDZ2116
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/25/2020
• 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: Male