MAUDE Adverse Event Report: Davol Inc., Sub. C.R. Bard, Inc. -1213643 Ventrio ST; Surgical Mesh

Catalog Number	5950050
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abscess (1690); Unspecified Infection (1930); Pain (1994); Insufficient Information (4580)
Date of Event	09/24/2020
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 #2).An additional emdr was submitted to represent the bard/davol mesh - composix l/p (device #1).Should additional information be provided, a supplemental emdr will be submitted.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol composix l/p on (b)(6) 2014 and ventrio st on (b)(6) 2020.As reported, the patient is making a claim for an adverse patient outcome against the both 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.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol composix l/p on (b)(6)2014 and ventrio st on (b)(6)2020.As reported, the patient is making a claim for an adverse patient outcome against the both 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)2014 - patient was diagnosed with ventral incisional hernia thereby underwent open repair with implant of bard composix l/p mesh (device 1).Per op notes "incision was made in the lower midline abdomen.Ventral hernia with incarcerated omentum was observed.The incarcerated omentum was lysed and returned to the abdomen.The hernia sac was excised.A bard composix l/p mesh (device 1) was placed in a sublay manner and sutured." (b)(6)2020 - patient was diagnosed with recurrent ventral incisional hernia with pain, thereby underwent open repair with implant of ventrio st mesh (device 2).Per op notes "a midline incision was made from just below the umbilicus to the pubic tubercle.Hernia sac, rectus muscles and fascia were observed, and the hernia sac was reduced.Old mesh (device 1) was noted intact.The hernia sac was reduced and excised.A ventrio st mesh (device 2) was placed and secured and using sutures." (b)(6)2020 - patient was diagnosed with deep wound infection, pain and abscess thereby underwent open repair with incision and drainage of deep wound abscess.Per op notes "an incision was made just below the skin level.An abscess was observed with fibrinous debris and some purulence at the level of wound below the umbilicus.The midline fascia was opened.The old meshes (device 1 and 2) were noted well incorporated.The mesh (device 1 and 2) was exposed over a small portion but was well incorporated and was not removed.The wound was explored and the wound was left open and packed with dressings.".
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-sep-2019) is considered to be a best estimate.Updated fields: a2, b2, b3, b4, b5, b7, d3, d4 (product lot no., product catalog no., expiry date, udi no), g3, g6, h2, h4, h6, h10.This supplemental emdr represents the bard/davol ventrio st mesh (device 2).An additional supplemental emdr was submitted to represent the bard/davol composix l/p 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 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 ; +1(401)825-8495
• MDR Report Key: 13306929
• Report Number: 1213643-2022-90242
• Device Sequence Number: 11609588
• Product Code: FTL
• UDI-Device Identifier: 00801741031540
• UDI-Public: (01)00801741031540(17)210828(10)HUDW1526
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2026

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: 08/28/2021
• Device Catalogue Number: 5950050
• Device Lot Number: HUDW1526
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2022
• Supplement Date Received by Manufacturer: 08/10/2026
• Initial Report FDA Received Date: 01/20/2022
• Supplement Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2019
• 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 Sex: Female