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

Catalog Number	0010213
Medical Device Problem Codes	Defective Device (2588); Material Deformation (2976); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Hernia (2240); Injury (2348); Disability (2371)
Date of Event	02/07/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The cause of the patient's post-op complications cannot be determined at this time.The patient's attorney alleges unspecified injuries and revision surgery; however, no details have been provided regarding the nature of the injury or surgery.No medical records have been provided.No lot number has been provided; therefore a review of the manufacturing records is not possible at this time.Based on the limited information provided at this time, no conclusions can be made.This emdr represents the bard/davol ventrio mesh (device #1).The patient's attorney did not make any allegations regarding the implanted bard/davol ventrio st device.Should additional information be provided a supplemental emdr will be submitted.Note: no sample returned.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2012: the patient underwent surgery for implant of an unspecified bard/davol ventrio (device #1).On (b)(6) 2014: the patient had unspecified injuries and underwent revision surgery as well as implant of an unspecified bard/davol ventrio st.As reported, the patient is only making a claim for an adverse patient outcome against the bard/davol ventrio (device #1).As alleged, 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
The following was alleged by the patient's attorney: (b)(6) 2012: the patient underwent surgery for implant of an unspecified bard/davol ventrio (device #1).(b)(6) 2014: the patient had unspecified injuries and underwent revision surgery as well as implant of an unspecified bard/davol ventrio st.As reported, the patient is only making a claim for an adverse patient outcome against the bard/davol ventrio (device #1).As alleged, 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) 2012 - patient was diagnosed with incisional hernia thereby underwent open repair with the implant of ventrio mesh (device 1).Per op notes, "a midline incision was made, a ventrio mesh (device 1) was placed to the fascia using prolene sutures." (b)(6) 2014 - patient was diagnosed with recurrent incarcerated incisional hernia thereby underwent open repair with removal of old mesh (device 1) and implant of ventrio st (device 2).Per op notes, "the previous mesh (device 1) was rolled up inferiorly and was removed.A ventrio st (device 2) was placed to the anterior abdominal wall using sutures.".
Additional Manufacturer Narrative
The cause of the patient's post-op complications cannot be determined at this time.The patient's attorney alleges unspecified injuries and revision surgery; however, no details have been provided regarding the nature of the injury or surgery.No medical records have been provided.No lot number has been provided; therefore a review of the manufacturing records is not possible at this time.Based on the limited information provided at this time, no conclusions can be made.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-nov-2010) is considered to be a best estimate.Updated fields: a2, b2, b4, b5, b6, b7, d4, d.6b (date of explant), g1, g3, g4, g6, h2, h4, 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.

• 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: 8165555
• Report Number: 1213643-2018-04771
• Device Sequence Number: 2025428
• Product Code: FTL
• UDI-Device Identifier: 00801741016400
• UDI-Public: (01)00801741016400(17)120528(10)HUUK0117
• 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: 2012
• 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): 12/18/2025

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: 05/28/2012
• Device Catalogue Number: 0010213
• Device Lot Number: HUUK0117
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 12/14/2018
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2010
• 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: 50 YR
• Patient Sex: Female