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

Catalog Number	0010211
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Inflammation (1932); Hernia (2240); Disability (2371)
Date of Event	12/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including permanent injury, hernia recurrence, adhesions, inflammation and subsequent surgical intervention.The instructions-for-use supplied with the device lists hernia recurrence, adhesions, and inflammation as possible complications.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Should additional information be provided, a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges that, on or about (b)(6) 2016, the patient underwent repair of an abdominal hernia and was implanted with a non-bard/davol mesh.On or about (b)(6) 2017, the patient underwent revision of the non- bard/davol mesh for the repair of an abdominal hernia and was implanted with a bard/davol ventrio mesh patch during this repair.On or about (b)(6) 2019, the patient underwent removal of the mesh products.The patient experienced and/or continues to experience severe and chronic pain/discomfort, inflammation, significant adhesions, recurrence and surgery to remove the mesh.Attorney also 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 further alleged that the device was defective.
Event or Problem Description
Attorney alleges that, on or about (b)(6) 2016, the patient underwent repair of an abdominal hernia and was implanted with a non-bard/davol mesh.On or about (b)(6) 2017, the patient underwent revision of the non- bard/davol mesh for the repair of an abdominal hernia and was implanted with a bard/davol ventrio mesh patch during this repair.On or about (b)(6) 2019, the patient underwent removal of the mesh products.The patient experienced and/or continues to experience severe and chronic pain/discomfort, inflammation, significant adhesions, recurrence and surgery to remove the mesh.Attorney also 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 further alleged that the device was defective.Addendum per additional information provided: (b)(6) 2017 - patient was diagnosed with ventral hernia thereby underwent open repair with the implant of ventrio mesh (device 1).Per operative notes, ¿the hernia sac was dissected.Ventrio mesh (device 1) was placed and secure it with suture.¿ (b)(6) 2019 - patient was diagnosed with recurrent ventral hernia, inflammation thereby underwent robotic assisted repair with explant of ventrio mesh (device 1) and implant of ventralight st w/ echo 2 mesh (device 2).Per operative notes, ¿hernia sac was dissected out.Ventrio mesh (device 1) was totally removed.Ventralight st w/ echo 2 mesh (device 2) was placed and secure it with suture.¿.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including permanent injury, hernia recurrence, adhesions, inflammation and subsequent surgical intervention.The instructions-for-use supplied with the device lists hernia recurrence, adhesions, and inflammation as possible complications.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Should additional information be provided, a supplemental emdr will be submitted.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct the udi no.And manufacturing date.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-jan-2017) is considered to be a best estimate.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: 11379035
• Report Number: 1213643-2021-01237
• Device Sequence Number: 3774004
• Product Code: FTL
• UDI-Device Identifier: 00801741016387
• UDI-Public: (01)00801741016387(17)200728(10)HUBN0061
• 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: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2025

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: 07/28/2020
• Device Catalogue Number: 0010211
• Device Lot Number: HUBN0061
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2017
• 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: Male
• Patient Weight: 123 KG