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	Adhesion(s) (1695); Hernia (2240)
Date of Event	12/09/2011
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2011- patient was diagnosed with incarcerated umbilical hernia thereby underwent open repair with implant of ventralex mesh (device 1).Per op notes, "the hernia sac with omentum was identified in umbilical region and the omentum was reduced.A ventralex mesh (device 1) was placed and sutured." (b)(6) 2011 - patient was diagnosed with incisional hernia, thereby underwent laparoscopic repair with implant of ventralight st mesh (device 2).(note: there is no operative notes provided for this procedure).(b)(6) 2015 - patient was diagnosed with recurrent incisional hernia, thereby underwent laparoscopic repair with implant of ventralight st using echo ps (device 3).Per op notes, "some adhesions of the omentum to the abdominal wall in upper abdomen was noted.The recurrence hernia was noted in central portion of previously placed mesh.The surface of mesh was cleared and the hernia sac was dissected.A ventralight st using echo ps (device 3) was placed in the abdomen and was sutured." (the previously placed mesh mentioned in the procedure was unknown).
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-oct-2010) is considered to be a best estimate.This emdr represents the ventralex mesh (device 1).An additional supplemental emdr was submitted to represent the ventralight st mesh (device 2).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: 50850437
• Report Number: 1213643-2026-01216
• Device Sequence Number: 10053451
• Product Code: FTL
• UDI-Device Identifier: 00801741016479
• UDI-Public: (01)00801741016479(17)151128(10)HUUJ1167
• 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
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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: 11/28/2015
• Device Catalogue Number: 0010302
• Device Lot Number: HUUJ1167
• 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: 09/09/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2010
• 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