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

Catalog Number	0010214
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Bacterial Infection (1735); Purulent Discharge (1812); Fistula (1862); Pain (1994); Hernia (2240); Injury (2348); Disability (2371); Impaired Healing (2378)
Date of Event	01/18/2017
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.No lot number has been provided; therefore a review of the manufacturing records is not possible.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) 2010.It is also alleged by patient's attorney that on 01/18/2017, the patient had unspecified injuries related to 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.".
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.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.Updated fields: a2, a4, b4, b5, b6, b7, d4 (product catalog no., corporate lot no., udi no.), d6.B (date of explant), g1, g3, g6, h2, h6, h10.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 an unspecified bard/davol ventrio on (b)(6) 2010.It is also alleged by patient's attorney that on (b)(6) 2017, the patient had unspecified injuries related to 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) 2010 ¿ patient was diagnosed with incisional hernia thereby underwent open repair with the implant of ventrio mesh.Per op notes, ¿an ventrio patch was placed in the peritoneal cavity and sutured to the anterior abdominal wall and tacked.¿ (b)(6) 2016 ¿ patient had a pain and diagnosed with incarcerated recurrent incisional hernia and umbilical hernia thereby underwent open repair with the implant of synthetic mesh.Per op notes, ¿a large incisional hernia was repaired using a synthetic mesh placed in abdominal cavity and secured using sutures.An umbilical hernia was reinforced with an onlay synthetic mesh and tacked.¿ (b)(6) 2017 ¿ patient was diagnosed with periumbilical infected mesh, hernia recurrence and chronic open wound thereby underwent open repair with the removal of mesh.Per op notes, ¿the wound was failed to heal.The underlying ventrio mesh, synthetic mesh and fistulas were dissected off the surrounding tissues and removed.The serial purulent cavity was evacuated.Adhesiolysis was performed.A synthetic mesh was placed and sutured.¿ (b)(6) 2017 ¿ patient was diagnosed with chronically incarcerated recurrent incisional hernia thereby underwent open repair with removal of synthetic mesh and implant of synthetic mesh.

• 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: 9324739
• Report Number: 1213643-2019-11091
• Device Sequence Number: 388159
• Product Code: FTL
• UDI-Device Identifier: 00801741016417
• UDI-Public: (01)00801741016417(10)DATB0009
• 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: 2010
• 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): 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 Catalogue Number: 0010214
• Device Lot Number: DATB0009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 07/15/2025
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 84 KG