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

Catalog Number	0010303
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Unspecified Infection (1930)
Date of Event	03/23/2011
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-sep-2009) is considered to be a best estimate.This mdr represents the mesh- ventralex (device #2).An additional supplemental emdr was submitted to represent the mesh- ventralex (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.
Event or Problem Description
Per information provided: on (b)(6) 2010 - patient was diagnosed with incisional hernia thereby underwent open repair with implant of two ventralex mesh (device #1 & #2).Per op notes, "two ventralex mesh (device #1 & #2) were placed into the fascia using sutures." on (b)(6) 2011 - patient was diagnosed with ventral incisional hernia with infected mesh thereby underwent repair with removal of mesh (device #1 & #2).Per op notes, "attention to the midline, where the umbilicus was resected.Dissection was carried down to the fascia, the old mass of infected tissue was resected which was densely adherent to the mesh.The mesh (device #1 & #2) was completely removed.A synthetic mesh was placed.".

• Brand Name: MESH - VENTRALEX
• 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: 22725210
• Report Number: 1213643-2025-00730
• Device Sequence Number: 18214814
• Product Code: FTL
• UDI-Device Identifier: 00801741016486
• UDI-Public: (01)00801741016486(17)140928(10)HUTI0704
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K132441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2025

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: 09/28/2014
• Device Catalogue Number: 0010303
• Device Lot Number: HUTI0704
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2009
• 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: 47 YR
• Patient Sex: Male