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	Abscess (1690); Unspecified Infection (1930); Seroma (2069); Hernia (2240); Injury (2348)
Date of Event	05/26/2011
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.Should additional information be provided a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges that on (b)(6) 2010, the patient underwent surgery for implant of an unspecified bard/davol ventrio patch.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.As reported, the patient is making a claim for an adverse patient outcome against the ventrio patch.As reported, the attorney alleges product is defective and that the patient experienced emotional distress.
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-jun-2009) is considered to be a best estimate.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 on (b)(6) 2010, the patient underwent surgery for implant of an unspecified bard/davol ventrio patch.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.As reported, the patient is making a claim for an adverse patient outcome against the ventrio patch.As reported, the attorney alleges product is defective and that the patient experienced emotional distress.Addendum per additional information provided: (b)(6) 2010- patient was diagnosed with recurrent ventral hernia thereby underwent open repair with implant of ventrio mesh.Per op notes, ¿the hernia sac with omentum was identified in the supraumbilical region and was dissected.A ventrio mesh was placed in the intraperitoneal cavity, tacked with sorbafix absorbable tacker and sutured¿.(b)(6) 2011- patient was diagnosed with abdominal wall abscess, thereby underwent open repair.Per op notes, ¿fluid collection in the abdominal region was noticed and evacuated out¿.(b)(6) 2011- patient was diagnosed with infected abdominal wall mesh, thereby underwent open repair with explant of ventrio mesh.Per op notes, ¿the infected ventrio mesh was excised completely.¿.
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.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 1: 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-jun-2009) is considered to be a best estimate.Addendum 2: h11: this supplemental emdr is submitted to document the results of dhr review performed.A review of the manufacturing records was performed and found the lot was manufactured according to specification.To date this is the only reported complaint for this lot of 154 units released for distribution.Updated fields: g6, h6, h10, h11.Corrected field: h4 (manufacturing date).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 on (b)(6) 2010, the patient underwent surgery for implant of an unspecified bard/davol ventrio patch.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.As reported, the patient is making a claim for an adverse patient outcome against the ventrio patch.As reported, the attorney alleges product is defective and that the patient experienced emotional distress.Addendum per additional information provided: (b)(6) 2010- patient was diagnosed with recurrent ventral hernia thereby underwent open repair with implant of ventrio mesh.Per op notes, ¿the hernia sac with omentum was identified in the supraumbilical region and was dissected.A ventrio mesh was placed in the intraperitoneal cavity, tacked with sorbafix absorbable tacker and sutured¿.(b)(6) 2011- patient was diagnosed with abdominal wall abscess, thereby underwent open repair.Per op notes, ¿fluid collection in the abdominal region was noticed and evacuated out¿.(b)(6) 2011- patient was diagnosed with infected abdominal wall mesh, thereby underwent open repair with explant of ventrio mesh.Per op notes, ¿the infected ventrio mesh was excised completely.¿.

• 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: 9220790
• Report Number: 1213643-2019-10124
• Device Sequence Number: 11350846
• Product Code: FTL
• UDI-Device Identifier: 00801741016417
• UDI-Public: (01)00801741016417(17)100628(10)HUTF2106
• 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: 2010
• Device Explanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/02/2026

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: 06/28/2010
• Device Catalogue Number: 0010214
• Device Lot Number: HUTF2106
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 11/24/2025; 01/13/2026
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 12/18/2025; 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2009
• 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: 52 YR
• Patient Sex: Male