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

Catalog Number	0010213
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190); Migration (4003)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Hernia (2240); Injury (2348)
Date of Event	12/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges surgical intervention; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represents the bard/davol ventrio mesh (device # 2).Additional emdrs were submitted to represent the bard/davol composix mesh e/x (device # 1) and the bard/davol ventrio mesh (device # 3).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 composix e/x and two ventrio patches on (b)(6) 2015 and/ or (b)(6) 2017.As reported, the patient is making a claim for an adverse patient outcome against all three hernia mesh devices.It is alleged that the patient had subsequent surgical intervention.It is also alleged that the patient experienced emotional distress and the device was defective.
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges surgical intervention; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Addendum: this supplemental emdr is submitted to document additional information provided.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-jul-2014) is considered to be a best estimate.This supplemental emdr represents the bard/davol ventrio mesh (device #2).Additional supplemental emdrs were submitted to represent the bard/davol mesh - composix e/x (device #1) and the bard/davol ventrio mesh (device #3).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
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol composix e/x and two ventrio patches on (b)(6) 2015 and/or (b)(6) 2017.As reported, the patient is making a claim for an adverse patient outcome against all three hernia mesh devices.It is alleged that the patient had subsequent surgical intervention.It is also alleged that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2015 - patient was diagnosed with ventral hernia thereby underwent laparoscopic repair with the implant of composix e/x mesh (device #1).Per op notes, ¿a composix e/x mesh (device #1) was placed with sutures.¿ (b)(6) 2015 - patient was diagnosed with ventral hernia and abdominal pain thereby underwent laparoscopic repair with lysis of adhesions and implant of ventrio mesh (device #2).Per op notes, ¿there were omental adhesions to the anterior abdominal wall which were taken down.The previous mesh (device #1) was identified just above the umbilicus and the mesh was slightly bunched up and displaced inferiorly.This is likely causing the patient¿s pain.Because of the mesh was displaced, another piece of ventrio mesh (device #2) was placed in that area using sutures.¿ (b)(6) 2017 - patient was diagnosed with recurrent ventral hernia and adhesions to the anterior abdominal wall thereby underwent laparoscopic repair with implant of ventrio mesh (device #3).Per op notes, ¿abdominal cavity was noted there were significant dense omental adhesions to the intra-abdominal wall with the previous mesh.The previous mesh had pulled away from that area causing a recurrence.A ventrio mesh (device #3) was placed into the abdominal cavity using sutures.¿ (b)(6) 2019 - patient was diagnosed with recurrent incisional hernia and abdominal pain secondary to contracted mesh thereby underwent open repair with the removal of mesh (device #1, #2 & #3).Per op notes, ¿identified the preperitoneal space and mesh.This mesh was completely removed.Then a biologic mesh was placed.¿.

• 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: 9481208
• Report Number: 1213643-2019-12212
• Device Sequence Number: 388461
• Product Code: FTL
• UDI-Device Identifier: 00801741016400
• UDI-Public: (01)00801741016400(17)170828(10)HUYG0994
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K100229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

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: 0010213
• Device Lot Number: HUYG0994
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 07/15/2025
• 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: 34 YR
• Patient Sex: Female
• Patient Weight: 77 KG