MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 MESH - VENTRALEX; SURGICAL MESH

Catalog Number	0010302
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	06/29/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2015: patient was diagnosed with umbilical and epigastric hernias thereby underwent open repair with implant of ventralex mesh (device 1 and 2).Per op notes, "there were two large fascia defects in the supraumbilical midline were noted.Both hernias were herniated with preperitoneal fat were amputated.Umbilical hernia was noted and reduced.Two ventralex mesh (device 1 and 2) were placed to cover the epigastrium and umbilical region and secured using sutures." (b)(6) 2020: patient was diagnosed with recurrent incisional hernia thereby underwent open repair with partial excision of ventralex mesh (device 1 and 2) implant of synthetic mesh.Per op notes, "the old meshes (device 1 and 2) were identified.Two separate layers of meshes were noted.Opening the top layer of the mesh.One of the layers had completely coiled itself and was trapping omentum within it was released.All the omentum freed from the mesh.Deep layer of mesh that was coiled itself was removed.The anterior layer of mesh was incorporated left in place.The recurrent hernia defect was noted and reduced.A synthetic mesh was placed and sutured.".
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-2014) 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 ; 8005566756
• MDR Report Key: 25175552
• Report Number: 1213643-2026-00639
• Device Sequence Number: 18783414
• Product Code: FTL
• UDI-Device Identifier: 00801741016479
• UDI-Public: (01)00801741016479(17)180428(10)HUYJ0849
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K132441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2026

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: 04/28/2018
• Device Catalogue Number: 0010302
• Device Lot Number: HUYJ0849
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2014
• 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: 66 YR
• Patient Sex: Male