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

Catalog Number	0010214
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240); Injury (2348); Disability (2371)
Date of Event	02/23/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges injuries and revision surgery; however, no details have been provided.The cause of the patient postoperative complications cannot be determined at this time.No lot number has been provided therefore a review of the manufacturing records is not possible at this time.Information is limited.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 an unspecified bard/davol ventrio on (b)(6) 2009.It is alleged by patient¿s attorney that on (b)(6) 2012, patient had unspecified injuries related a defect in the ventrio and underwent revision surgery.As reported, the patient is making a claim for an adverse patient outcome against the ventrio.As reported, the 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.".
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol ventrio on (b)(6) 2009.It is alleged by patient¿s attorney that on (b)(6) 2012, patient had unspecified injuries related a defect in the ventrio and underwent revision surgery.As reported, the patient is making a claim for an adverse patient outcome against the ventrio.As reported, the 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." addendum per additional information provided: (b)(6) 2009 - patient was diagnosed with large umbilical hernia thereby underwent open repair with the implant of ventrio mesh (device #1) on (b)(6) 2009.Per operative notes, ¿a large umbilical hernia sac was identified.The sac was dissected and removed.A circular ventrio mesh was placed and secure it with suture¿ (b)(6) 2012 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair with explant of ventrio mesh (device #1) and implant of synthetic mesh.Per operative notes, ¿the hernia sac was excised from the fascial edges.Ventrio mesh (device #1) was excised fully.A synthetic mesh was then placed and secure it with suture.¿ attorney alleges that the patient had adhesions, pain, hernia recurrence and emotional injuries.
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges injuries and revision surgery; however, no details have been provided.The cause of the patient postoperative complications cannot be determined at this time.No lot number has been provided therefore a review of the manufacturing records is not possible at this time.Information is limited.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: 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: 8769225
• Report Number: 1213643-2019-05828
• Device Sequence Number: 14119833
• Product Code: FTL
• UDI-Device Identifier: 00801741016417
• UDI-Public: (01)00801741016417(10)DASL0006
• 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: 2009
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2025

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 Catalogue Number: 0010214
• Device Lot Number: DASL0006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2019
• Supplement Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 07/08/2019
• Supplement Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 54 YR
• Patient Sex: Female