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	Abdominal Pain (1685); Adhesion(s) (1695); Hernia (2240)
Date of Event	06/25/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2011 - patient was diagnosed with epigastric hernia and umbilical hernia thereby underwent open repair with implant of ventralex mesh (device 1 and 2).Per op notes, "a small incision was made in the epigastrium region and dissected down on the large hernia sac.The hernia sac was freed up and excised.A large ventralex mesh (device 1) was placed and secured through both the superior and inferior areas with suture.A keyhole incision was made to the right of the umbilicus around the umbilicus.The hernia sac was identified and amputated.The hernia sac was closed with suture, reduced the hernia sac and developed a preperitoneal plane.A medium ventralex mesh (device 2) was placed in this preperitoneal space and secured with suture." (b)(6) 2015 - patient was diagnosed with recurrent incisional hernia thereby underwent laparoscopic repair with implant of composix l/p mesh (device 3).Per op notes, "multiple swiss cheese defects extending the length of the midline abdominal incision was made.Omental adhesions were to the anterior abdominal wall were taken down.The defect was measured and a composix l/p mesh (device 3) was placed to cover the defect and secured with 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.Note, the manufacturing date (15-jan-2011) is considered to be a best estimate.This emdr represents the ventralex mesh (device 2).An additional supplemental emdr was submitted to represent the ventralex mesh (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.

• 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: 50801945
• Report Number: 1213643-2026-01209
• Device Sequence Number: 21468736
• Product Code: FTL
• UDI-Device Identifier: 00801741016479
• UDI-Public: (01)00801741016479(17)160228(10)HUVA1639
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K021736
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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: 02/28/2016
• Device Catalogue Number: 0010302
• Device Lot Number: HUVA1639
• 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: 09/10/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2011
• 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: Male
• Patient Weight: 302 LB