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

Catalog Number	0010302
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240)
Date of Event	03/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges post implant of ventralex mesh the patient was diagnosed with recurrent umbilical hernia as the edge of the mesh was herniated and also the mesh was adherent to the underside of the umbilical stalk.The patient's attorney alleges that the patient had revision hiatal hernia repair was performed with excision of mesh.The patient's attorney also alleges "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient."; however, no details have been provided.Note, the manufacturing date (15-jan-2019) is considered to be a best estimate.This emdr represents the ventralex mesh (device 1).An additional emdr was submitted to represent the ventrio mesh (device 2).Should additional information be provided, a supplemental emdr will be submitted.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
Per information provided: attorney alleges that the patient underwent umbilical hernia repair with implant of bard/davol ventralex mesh on (b)(6) 2019.Post implant patient was diagnosed with recurrent umbilical hernia as the edge of the mesh was herniated and also the mesh was adherent to the underside of the umbilical stalk.Laparoscopic revision hiatal hernia repair was performed with excision of mesh.Along with implant of bard/davol ventrio mesh on (b)(6) 2025.Patient continued experiencing abdominal pain, tearing sensations, and swelling.Attorneys alleges that the patient experiencing recurrence, chronic pain, disability which have impaired daily activities and underwent additional surgical intervention.Attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." it is also alleged that the device was defective.

• Brand Name: MESH - VENTRALEX
• 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: 25315855
• Report Number: 1213643-2026-00689
• Device Sequence Number: 5181451
• Product Code: FTL
• UDI-Device Identifier: 00801741016479
• UDI-Public: (01)00801741016479(17)220828(10)HUDN2056
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K132441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2022
• Device Catalogue Number: 0010302
• Device Lot Number: HUDN2056
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2019
• 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