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

Catalog Number	5950040
Medical Device Problem Codes	Defective Device (2588); Material Deformation (2976); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Nerve Damage (1979); Pain (1994); Hernia (2240)
Date of Event	01/04/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information received, no conclusions can be made.As reported, post implant of ventrio st mesh, patient was diagnosed with nerve damage, hernia recurrence, pain and mesh deformation.The instructions-for-use supplied with the device lists hernia recurrence 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-dec-2013) is considered to be a best estimate.This emdr represents the ventrio st - left (device #3).Additional supplemental emdr's were submitted to represent the mesh ¿ ventralex (device #1); ventrio st - right (device #2) and perfix plug (device #4).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.H3 other text: not returned.
Event or Problem Description
Per information provided: on (b)(6) 2014 - patient was diagnosed with ventral hernia thereby underwent repair with the implant of ventralex mesh (device#1), right inguinal hernia with the implant of ventrio st mesh (device #2) and left inguinal hernia with the implant of ventrio st (device #3).Ni-ni-2014 - patient had pain.Ni-ni-2015 to ni-ni-2016 - patient had groin pain, nerve dissection, revision of mesh.On (b)(6) 2016 - patient was diagnosed with left inguinal hernia with the implant of perfix plug (device #4) and had revision of crumpled mesh, dissection of ilioinguinal nerve.Ni-ni-2017 to ni-ni-2018 - patient had urology and pain.Attorney alleged that the patient had hernia recurrence, mesh shrinkage, nerve damage, pain & suffering.Difficulty and pain with urination, urinary incontinence, kidney pain, sexual dysfunction, sporadic and severe cramps.Patient suffered severe damage to his spermatic cord, left testicle, and left groin area.

• Brand Name: VENTRIO ST
• 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: 21437033
• Report Number: 1213643-2025-090103
• Device Sequence Number: 14543130
• Product Code: FTL
• UDI-Device Identifier: 00801741031533
• UDI-Public: (01)00801741031533(17)151228(10)HUXL0806
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/21/2025

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: 12/28/2015
• Device Catalogue Number: 5950040
• Device Lot Number: HUXL0806
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2013
• 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; Disability
• Patient Age: 60 YR
• Patient Sex: Male