MAUDE Adverse Event Report: Davol Inc., Sub. C.R. Bard, Inc. -1213643 Mesh - Ventralex; Surgical Mesh

Catalog Number	0010302
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Purulent Discharge (1812); Unspecified Infection (1930); Hernia (2240)
Date of Event	01/28/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on b)(6) 2011 ¿ patient was diagnosed with multiple incarcerated ventral incisional hernias thereby underwent open repair with the implant of ventralex mesh (device 1, 2).Per op notes, ¿the hernia sac was identified.Hernias were noted in inferior portion and periumbilical area.A ventralex mesh (device 1) was placed in right upper quadrant using sutures.The periumbilical hernias were noted.A medium ventralex mesh (device 2) was placed against the fascial edge and secured using sutures.¿ on (b)(6) 2013 ¿ patient was diagnosed with recurrent incarcerated multiple ventral hernia, infected mesh with necrotic fasciitis, abscess thereby underwent open repair with the removal of meshes (device 1, 2).Per op notes, ¿the larger hernia sac or two was identified.A significant chronic inflammation with necrotic fascia.The hernia sac was resected.A incarcerated hernia which was located just right and lateral to the umbilicus.The two infected mesh was identified with obvious purulent fluid were removed.A synthetic mesh was placed and secured to the defect using sutures.¿.
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.This mdr represents the ventralex mesh (device 2).An additional supplemental emdr was submitted to represent the ventralex mesh (device 1).Note, the manufacturing date (15-may-2011) 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: 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 ; +1(800)556-6756
• MDR Report Key: 50942962
• Report Number: 1213643-2026-01260
• Device Sequence Number: 9623898
• Product Code: FTL
• UDI-Device Identifier: 00801741016479
• 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: 2011
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: 05/28/2016
• Device Catalogue Number: 0010302
• Device Lot Number: HUVE0814
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2011
• 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 Sex: Female