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

Catalog Number	0010301
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Hernia (2240); Obstruction/Occlusion (2422)
Date of Event	08/11/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2008- patient was diagnosed with two incisional hernias thereby underwent open repair with implant of ventralex mesh (device 1 and device 2).Per op notes, "an incision was made through the left lateral scar, approximately two- third of the way between the umbilicus and pubis.Some areas of fat necrosis and a large defect with a loop of bowel adherent to a hernia sac were identified.The bowel was taken down.A ventralex mesh (device 1) was placed in the wound and the wound was partially closed over the mesh and was secured with tacks to the fascia.The umbilicus was opened and below which another transverse incision was made.A large omental fat from the small defect at the base of the umbilicus was identified, the fat was reduced and a ventralex mesh (device 2) was placed and was secured with tacks." (b)(6) 2015- patient was diagnosed with abdominal pain and incisional hernia, adhesion, obstruction thereby underwent open repair with excision of ventralex mesh (device 1 and device 2) and implant of xenmatrix graft (device 3).Per op notes, "a sterile incision was made above the umbilicus down to the pubis.The large amount of calcified mesh that was doubled up and invaginated from the incisional hernia was identified.The adhesions were dissected, which was holding the bowel to the anterior abdominal wall.The previously placed ventralex mesh (device 1 and 2) was excised.A large band of adhesive tissue towards the posterior aspect of the abdomen was excised to relieve the small bowel obstruction.The hernia was assessed and muscle advancement flap was performed.A xenmatrix graft (device 3) was placed and secured with sutures affixing it on a pre-fascial type of fashion.".
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-may-2008) 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: 50052060
• Report Number: 1213643-2026-00957
• Device Sequence Number: 9589607
• Product Code: FTL
• UDI-Device Identifier: 00801741000355
• UDI-Public: (01)00801741000355(17)130628(10)HUSE0528
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2026

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: 06/28/2013
• Device Catalogue Number: 0010301
• Device Lot Number: HUSE0528
• 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: 07/21/2026
• Initial Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2008
• 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