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

Catalog Number	0010211
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994)
Date of Event	12/01/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6)2014 - patient was diagnosed with bilateral inguinal hernia with left recurrent thereby underwent laparoscopic repair with two ventrio mesh (device #1 & #2).Per operative notes, ¿direct hernia was cleared and then two oval ventrio (device #1 & #2) patches were placed in abdomen on each side.Each one was tacked to cover up the inguinal region.¿ (b)(6)2014 - patient was diagnosed with spermatic cord entrapment and chronic pain thereby underwent repair with removal of both meshes (device #1 & #2).Per operative notes, ¿adhesions were taken down.Both meshes and all tacks were removed.¿ attorney alleges that the patient had adhesions, hernia recurrence, pain with urination, spermatic cord entrapment and emotional injuries.
Additional Manufacturer Narrative
Based on the information received, no conclusions can be made.Per medical records review, about 1 month post implant of ventrio mesh, patient was diagnosed with adhesions and pain thereby underwent repair with removal of mesh.The instructions-for-use supplied with the device lists adhesions and pain as possible complications.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Note, the manufacturing date (15-jul-2014) is considered to be a best estimate.This emdr represents the bard/davol ventrio mesh (device #2).An additional supplemental emdr was submitted to represent the bard/davol ventrio mesh (device #1) 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 MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 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 ; 4018258495
• MDR Report Key: 21685342
• Report Number: 1213643-2025-090132
• Device Sequence Number: 12966748
• Product Code: FTL
• UDI-Device Identifier: 00801741016387
• UDI-Public: (01)00801741016387(17)170828(10)HUYG0979
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K100229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/25/2025

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: 08/28/2017
• Device Catalogue Number: 0010211
• Device Lot Number: HUYG0979
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2014
• 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: 36 YR
• Patient Sex: Male
• Patient Weight: 103 KG