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

Catalog Number	0010219
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Hernia (2240); Disability (2371); Obstruction/Occlusion (2422)
Date of Event	12/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges "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"; 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).An additional emdr was submitted to represent the bard/davol ventrio mesh (device #1).Note, as a specific date was not provided, the date of event was estimated as (b)(6) 2019.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 two unspecified bard/davol ventrio on (b)(6) 2013 and (b)(6) 2014.As reported, the patient is making a claim for an adverse patient outcome against both devices.It is alleged that the patient's bowel obstruction was diagnosed in 2019.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." it is also alleged that the patient experienced emotional distress and the device was defective.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of two unspecified bard/davol ventrio on (b)(6) 2013 and (b)(6) 2014.As reported, the patient is making a claim for an adverse patient outcome against both devices.It is alleged that the patient's bowel obstruction was diagnosed in 2019.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." it is also alleged that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2013 - patient was diagnosed with recurrent incisional ventral hernia thereby underwent laparoscopic repair with implant of ventrio mesh (device #1).Per operative notes, ¿the previous biological mesh was not durable, the defect rise inferior to the mesh.The hernia defect was reduced.A ventrio mesh (device #1) was placed and tacked.¿ (b)(6) 2014 - patient was diagnosed with recurrent ventral hernia thereby underwent laparoscopic repair with excision of mesh (device #1) and implant of ventrio mesh (device #2).Per operative notes, ¿the adhesions of midline were lysed.The previous mesh did not cover the area of defect, the old mesh was removed.A ventrio mesh (device #2) was placed and sutured.¿ (b)(6) 2019 - patient was diagnosed with small bowel obstruction and recurrent ventral hernia thereby underwent open repair with implant of biological mesh.Per operative notes, ¿the scar tissue was excised.The obstructed small bowel was reduced.The previous mesh was intact and covered the defect.The new hernia defect was repaired with biological mesh and sutured.¿.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges "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"; 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).An additional emdr was submitted to represent the bard/davol ventrio mesh (device #1).Note, as a specific date was not provided, the date of event was estimated as 15-jun-2019.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct the date of event.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-oct-2013) is considered to be a best estimate.Corrected field: b3 (date of event).This supplemental emdr represents the ventrio mesh (device #2).An additional supplemental emdr was submitted to represent the ventrio mesh (device #1).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. -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: 11267566
• Report Number: 1213643-2021-00610
• Device Sequence Number: 3286499
• Product Code: FTL
• UDI-Device Identifier: 00801741016462
• UDI-Public: (01)00801741016462(17)161128(10)HUXJ2576
• 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: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2025

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: 11/28/2016
• Device Catalogue Number: 0010219
• Device Lot Number: HUXJ2576
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2013
• 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: 57 YR
• Patient Sex: Female