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); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240); Injury (2348); Disability (2371); Obstruction/Occlusion (2422)
Date of Event	09/22/2017
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 st (device #3).Additional emdrs were submitted to represent the bard/davol composix e/x (device #1) and the bard/davol ventralex st (device #2).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 the implant of unspecified bard/davol composix e/x, ventralex st and ventrio st on (b)(6) 2007 and/or (b)(6) 2014 and/or (b)(6) 2019.As reported, the patient is making a claim for an adverse patient outcome against all devices.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.
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.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-apr-2014) is considered to be a best estimate.Updated fields: a2, a4, b2 (outcomes attributed to adv ev), b3, b4, b5, b6, b7, d4 (product catalog no., corporate lot no., udi no., expiry date), d.6a (date of implant), d.6b (date of explant), g3, g6, h2, h4, h6, h10.This supplemental emdr represents the bard/davol ventrio st (device 2).Additional supplemental emdrs were submitted to represent the bard/davol mesh - composix e/x (device 1), ventralex st (device 3).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 the patient underwent surgery for the implant of unspecified bard/davol composix e/x, ventralex st and ventrio st on (b)(6) 2007 and/or (b)(6) 2014 and/or (b)(6) 2019.As reported, the patient is making a claim for an adverse patient outcome against all devices.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) 2007 - patient was diagnosed with incarcerated ventral recurrent hernia thereby underwent laparoscopic repair with the implant of composix e/x mesh (device 1).Per operative notes, ¿the hernia sac was dissected.A composix e/x mesh (device 1) was placed into intra-abdominal cavity and secure it with suture.¿ (b)(6) 2014 - patient was diagnosed with recurrent incarcerated incisional hernia, adhesion thereby underwent open repair with implant one ventrio st mesh (device 2).Per operative notes, ¿adhesions were taken down.Hernia sac was dissected.A ventrio st mesh (device 2) was placed and secure it with suture.¿ (b)(6) 2017 - patient was diagnosed with incarcerated recurrent ventral hernia with small bowel obstruction with extensive intra-abdominal adhesion, pain thereby underwent open repair with explant of composix e/x mesh (device 1) and ventrio st mesh (device 2).Per operative notes, ¿all adhesions and bowel obstructions were taken down.Hernia sac was dissected out.Previously placed composix e/x mesh (device 1) and ventrio st mesh (device 2) were totally removed.The wound was irrigated.The defect was closed with suture.¿ (b)(6) 2019 - patient was diagnosed with two ventral hernias, adhesions thereby underwent open repair with implant of ventralex st mesh (left device 3) and ventrio st mesh (right device 4).Per operative notes, ¿right and left side hernia sac were dissected out.In left and right side ventralex st mesh (left device 3) and ventrio st mesh (right device 4) were placed and secure it with suture.¿.

• 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: 10557904
• Report Number: 1213643-2020-08533
• Device Sequence Number: 2793678
• Product Code: FTL
• UDI-Device Identifier: 00801741031519
• UDI-Public: (01)00801741031519(17)160428(10)HUYD0307
• 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: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2025

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: 04/28/2016
• Device Catalogue Number: 5950020
• Device Lot Number: HUYD0307
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 09/20/2020
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2014
• 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: 52 YR
• Patient Sex: Male
• Patient Weight: 100 KG