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

Catalog Number	0010213
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Hernia (2240); Injury (2348); Disability (2371)
Date of Event	05/12/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.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) 2013.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) 2013.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: on (b)(6) 2013 - patient was diagnosed with umbilical hernia thereby underwent open repair with the implant of ventrio mesh.Per operative notes, ¿a large umbilical hernia from surrounding tissue was dissected.A circular ventrio mesh was placed subfascially and secured using sutures.¿ on (b)(6) 2014 - patient had wound check and diagnosed with recurrent umbilical hernia thereby underwent removal of mesh which was not incorporated well.(note: there is no op notes were provided for medical records).Attorney alleges that the patient had mesh migration, pain & emotional injuries.
Additional Manufacturer Narrative
At this time no conclusions can be made.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.Based on the additional information received, there is no change to initial determination, no conclusions can be made.Per medical records review, about 5 months post implant of ventrio mesh, patient was diagnosed with hernia recurrence thereby underwent repair with removal of mesh.The instructions-for-use supplied with the device list hernia recurrence as a possible complication.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Note, the manufacturing date (15-jan-2013) is considered to be a best estimate.Updated fields.(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.

• 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: 8914870
• Report Number: 1213643-2019-07324
• Device Sequence Number: 19285554
• Product Code: FTL
• UDI-Device Identifier: 00801741016400
• UDI-Public: (01)00801741016400(17)160128(10)HUXA0272
• 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: 2013
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

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: 01/28/2016
• Device Catalogue Number: 0010213
• Device Lot Number: HUXA0272
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2013
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 104 KG