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

Catalog Number	0010217
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Purulent Discharge (1812); Unspecified Infection (1930); Seroma (2069); Injury (2348); Obstruction/Occlusion (2422)
Date of Event	01/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made to what extent the bard/davol ventrio may have caused or contributed to the reported event.The cause of the patient postoperative complications cannot be determined at this time.The patient's attorney alleges subsequent surgical intervention; however, no details have been provided.No lot number has been provided therefore a review of the manufacturing records is not possible at this time.Information is limited.Should additional information be provided a supplemental emdr will be submitted.Not returned.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2016: the patient underwent surgery for implant of an unspecified bard/davol ventrio patch.The patient had subsequent surgical intervention due to the hernia mesh device(s).The patient is making a claim for an adverse patient outcome against the bard/davol ventrio patch.The attorney alleges patient experienced emotional distress and the device was defective.
Additional Manufacturer Narrative
At this time no conclusions can be made to what extent the bard/davol ventrio may have caused or contributed to the reported event.The cause of the patient postoperative complications cannot be determined at this time.The patient's attorney alleges subsequent surgical intervention; however, no details have been provided.No lot number has been provided therefore a review of the manufacturing records is not possible at this time.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-2015) is considered to be a best estimate.Updated fields: a2, a4, b3, b4, b5, b6, b7, d4 (product catalog no., corporate lot no., expiry date, udi no.), d6b (date of explant), g1, g3, 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.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2016: the patient underwent surgery for implant of an unspecified bard/davol ventrio patch.The patient had subsequent surgical intervention due to the hernia mesh device(s).The patient is making a claim for an adverse patient outcome against the bard/davol ventrio patch.The attorney alleges patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2016 - patient was diagnosed with incarcerated small bowels, 2 separate ventral hernias in the umbilical, supraumbilical and subxiphoid region thereby underwent laparoscopic repair with the implant of ventrio mesh.Per operative notes, ¿an incision was made in the supraumbilical midline through panniculus to the anterior fascia.Extensive adhesions were taken down.Hernia sacs were removed.A ventrio mesh was placed into the intraabdominal cavity and secure it with sutures.¿ (b)(6) 2017 - patient was diagnosed with small bowel obstruction, adhesions, abscess, infected mesh, seroma, purulent discharge thereby underwent laparoscopic repair with explant of ventrio mesh.Per operative notes, ¿a vertical midline incision was made through skin and subcutaneous tissue.Purulent fluid was encountered.There was chronic small bowel obstruction noted under the mesh, which was removed entirely.All adhesions, seroma, and abscess were drained and removed.Infected ventrio mesh was removed from intraabdominal wall and secure it with sutures.The defect was closed with sutures.¿ (b)(6) 2017 to (b)(6) 2018 - patient was diagnosed with necrotic eschar skin and infected wound thereby underwent repair with debridement of infected necrotic eschar skin and fat.(b)(6) 2022 - patient was diagnosed with small bowel obstruction, intra-abdominal adhesion, recurrent incisional ventral hernia thereby underwent open repair with implant of biological mesh.

• 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: 8287143
• Report Number: 1213643-2019-00541
• Device Sequence Number: 14050723
• Product Code: FTL
• UDI-Device Identifier: 00801741016448
• UDI-Public: (01)00801741016448(17)180428(10)HUZD0177
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K100229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 10/29/2025

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: 04/28/2018
• Device Catalogue Number: 0010217
• Device Lot Number: HUZD0177
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2019
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2015
• 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: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 99 KG