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

Catalog Number	0010211
Medical Device Problem Codes	Defective Device (2588); Material Deformation (2976); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Purulent Discharge (1812); Unspecified Infection (1930); Pain (1994); Injury (2348); Disability (2371)
Date of Event	09/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges that the patient had subsequent surgical intervention and "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.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, as a specific explant ad event dates were not provided, the date of explant and the date of event were estimated as (b)(6) 2017.Should additional information be provided, a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol 3dmax and ventrio.As reported, the patient is making a claim for an adverse patient outcome against the ventrio which was implanted on (b)(6) 2016.It is alleged that the patient's mesh removal occurred in 2017.Attorney also 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 patient experienced emotional distress and the device was defective.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges that the patient had subsequent surgical intervention and "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.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, as a specific explant ad event dates were not provided, the date of explant and the date of event were estimated as (b)(6) 2017.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct date of event and date of explant.Root cause is inconclusive, no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.Note, the manufacturing date (15-feb-2015) is considered to be a best estimate.Updated fields: a2, b4, b5, b7, d3, d4, g3, g6, h2, h4, h6, h10, h11.Corrected fields: b3 (date of event), d.6b (date of explant).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
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol 3dmax and ventrio.As reported, the patient is making a claim for an adverse patient outcome against the ventrio which was implanted on (b)(6) 2016.It is alleged that the patient's mesh removal occurred in 2017.Attorney also 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 patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2016- patient was diagnosed with incarcerated incisional and ventral hernia, recurrent right inguinal hernia thereby underwent robotic-assisted laparoscopic repair with implant of ventrio mesh (device 1) for incisional ventral hernia and 3dmax (device 2) for right inguinal hernia.Per op notes, ¿indirect and component of direct hernia was identified in the right inguinal region.A 3dmax mesh (device 2) was placed in the right inguinal region, sutured using absorbable suture.Then, incarcerated incisional hernia was identified in the epigastric region and ventrio mesh (device 1) was placed and sutured¿.(b)(6) 2017 - patient was diagnosed with infected abdominal wall mesh thereby underwent open repair with explant of ventrio mesh (device 1).Per op notes, ¿the ventrio mesh (device 1) had folded upon itself was excised.Purulent drainage was noted from bottom of mesh.The omentum adherent to the mesh was taken down.¿.

• Brand Name: VENTRIO 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 ; 4018258495
• MDR Report Key: 11191074
• Report Number: 1213643-2021-00260
• Device Sequence Number: 14422739
• Product Code: FTL
• UDI-Device Identifier: 00801741016387
• UDI-Public: (01)00801741016387(17)180328(10)HUZB1674
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K100229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

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: 03/28/2018
• Device Catalogue Number: 0010211
• Device Lot Number: HUZB1674
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 01/18/2021
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2015
• 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: Disability; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male