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	Abscess (1690); Bacterial Infection (1735); Purulent Discharge (1812)
Date of Event	09/05/2008
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2008 - patient was diagnosed with umbilical hernia thereby underwent open repair with the implant of ventralex mesh on (b)(6) 2008.Per operative notes, "the hernia sac was circumferentially dissected out.A small defect was made and a ventralex mesh was placed inside the defect and sutured." (b)(6) 2008 - patient was diagnosed with wound infection and abscess thereby underwent incision and drainage.(b)(6) 2008 - patient was diagnosed with infected mesh thereby underwent open repair with explant of mesh.Per operative notes, "the mesh was removed, and a large collection of pus was noted and suctioned out.The defect was closed with sutures." (b)(6) 2008 - patient was diagnosed with ventral umbilical hernia thereby underwent laparoscopic repair with implant of synthetic mesh.(b)(6) 2015 - patient was diagnosed with recurrent umbilical hernia thereby underwent excision of suture granuloma and fascial defect repair.Attorney alleges that the patient had abscess, adhesions, infections, scar tissue, pain, hernia recurrence and emotional injuries.
Additional Manufacturer Narrative
Based on the information received, no conclusion can be made.Per medical records review, about 4 months post implant of ventralex mesh, patient was diagnosed with bacterial infection, purulent discharge, abscess and removal of the mesh.The instructions-for-use supplied with the device list infection as a possible complication.In regard to the infection, the warning section of the ifu states "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the mesh." should additional information be provided a supplemental emdr will be submitted.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: 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: 21761551
• Report Number: 1213643-2025-00296
• Device Sequence Number: 18304714
• Product Code: FTL
• UDI-Device Identifier: 00801741016486
• UDI-Public: (01)00801741016486(17)120828(10)HURF1599
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K021736
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/25/2025

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: 08/28/2012
• Device Catalogue Number: 0010303
• Device Lot Number: HURF1599
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2025
• Initial Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 40 YR
• Patient Sex: Female