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

Catalog Number	0010211
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	05/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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-feb-2015) 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.
Event or Problem Description
Per information provided: (b)(6) 2015 ¿ patient was diagnosed with left inguinal hernia; epigastric incisional hernia thereby underwent open repair with the implant of perfix plug (device 1) in left inguinal region and ventrio mesh (device 2) in epigastric region.Per operative notes, ¿a left indirect inguinal hernia was noted.Perfix plug (device 1) was placed through the internal ring and an onlay patch was secured to pubic tubercle, shelving edge of inguinal ligament using sutures.On epigastric region.An oval piece of ventrio mesh (device 2) was placed into abdominal cavity using tacks.¿ (b)(6) 2017 ¿ patient was diagnosed with recurrent ventral hernia thereby underwent open repair with the implant of ventralight st mesh (device 3).Per operative notes, ¿the ventral hernia was identified lateral and superior edge of previous mesh.Adhesions were lysed.A ventralight st mesh (device 3) was placed to cover the defect using sutures.The previously placed mesh (device 2) was incorporated into closure for overlap.¿ (b)(6) 2018 ¿ patient was diagnosed with recurrent left inguinal hernia thereby underwent open repair with the implant of perfix plug (device 4).Per operative notes, ¿well incorporated mesh and direct defect at the superomedial aspect was identified.A large perfix plug patch (device 4) was placed in the floor of inguinal canal and secured using sutures.¿ (b)(6) 2019 ¿ patient was diagnosed with multiply recurrent left inguinal hernia thereby underwent open repair with the implant of perfix plug (device 5).Per operative notes, ¿the mesh (device 4) had just lifted from pubic tubercle.A medium perfix plug (device 5) was placed into the direct recurrence and tacked around the edge of recurrence.An overlay mesh placed over the repair.".

• 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 ; 8005566756
• MDR Report Key: 23083318
• Report Number: 1213643-2025-00867
• Device Sequence Number: 4749024
• Product Code: FTL
• UDI-Device Identifier: 00801741016387
• UDI-Public: (01)00801741016387(17)180328(10)HUZB1674
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2025

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: 03/28/2018
• Device Catalogue Number: 0010211
• Device Lot Number: HUZB1674
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2015
• 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: 58 YR
• Patient Sex: Male