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

Catalog Number	5950020
Medical Device Problem Codes	Defective Device (2588); Material Deformation (2976); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Unspecified Infection (1930); Pain (1994); Hernia (2240); Peritonitis (2252); Injury (2348); Disability (2371); Obstruction/Occlusion (2422); Bowel Perforation (2668)
Date of Event	10/01/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time 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 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.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 st on (b)(6) 2012.As reported, the patient is making a claim for an adverse patient outcome against the ventrio st.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 an unspecified bard/davol ventrio st on (b)(6) 2012.As reported, the patient is making a claim for an adverse patient outcome against the ventrio st.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: on (b)(6) 2012 ¿ patient was diagnosed with two ventral incarcerated incisional hernia thereby underwent laparoscopic repair with the implant of ventrio st mesh.Per op notes, ¿a ventrio st mesh was inserted through the incision at the umbilicus, over the incarcerated hernia and tacked using sorbafix tacker.¿ on (b)(6) 2015 ¿ patient was diagnosed with recurrent incisional hernia thereby underwent robotic assisted repair with the partial removal of mesh.Per op notes, ¿the adhesion was taken down.The synthetic mesh was tagged into peritoneal cavity and old mesh was completely off the abdominal wall and clumped up with severe adhesion of omentum were removed.¿ on (b)(6) 2015 ¿ patient was diagnosed with peritonitis, abdominal wall cellulitis, infected mesh thereby underwent open repair with the removal of mesh.Per op notes, ¿lysis of adhesion of small bowel, the distal ileum with perforation was resected and the synthetic and the remaining of ventrio st mesh was removed.Then, anastomosis was performed.¿ on (b)(6) 2016 ¿ patient was diagnosed with recurrent incisional hernia thereby underwent primary closure suing suture.¿.
Additional Manufacturer Narrative
At this time 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 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.H11: this is an addendum to the initial emdr submitted (mdr_number: 1213643-2020-01375).It was identified that the emdr is a duplicate of a previously reported event (mdr_number: 1213643-2019-05775).As such, this supplemental emdr is submitted to report the information.Note, the manufacturing date (15-feb-2012) is considered to be a best estimate.Updated fields: a2, b2, b3, b4, b5, b6, b7, d4 (product catalog no., corporate lot no., udi no., expiry date), d6.B (date of explant), g1, g3, g6, h2, h4, h6, h10, h11.Should additional information be provided, a supplemental emdr will be submitted.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 ST
• 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: 9720040
• Report Number: 1213643-2020-01375
• Device Sequence Number: 366770
• Product Code: FTL
• UDI-Device Identifier: 00801741031519
• UDI-Public: (01)00801741031519(17)140228(10)HUWB1438
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2025

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: 02/28/2014
• Device Catalogue Number: 5950020
• Device Lot Number: HUWB1438
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2020
• Supplement Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2012
• 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: Life Threatening; Disability; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female