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

Catalog Number	5950009
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Fistula (1862); Unspecified Infection (1930); Hernia (2240)
Date of Event	05/04/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2011 - patient was diagnosed with recurrent incarcerated incisional hernia thereby underwent laparoscopic repair with the implant of composix kugel meshes (device 1, device 2).Per op notes, "the fascial defect was in the right side of the epigastrium.A prior mesh material that had a lattice type appearance was noted adherent to the anterior abdominal wall.A large oval composix kugel mesh (device 1) was placed into peritoneal cavity and centered over the defect using sutures.The fascial tissue in the midline just cephalad to the extent of the mesh in the xiphoid region has the appearance of diastases and seems tenuous.An additional small oval composix kugel mesh (device 2) was placed to reinforce the area using tacks." on (b)(6) 2018 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair with the implant of ventralex mesh (device 3).Per op notes, "the hernia sac was identified at supraumbilical and extending off to the left side.The adhesions to the omentum and sac were taken down.The defect was at the inferior edge of previous mesh (device 1, device 2).A large ventralex mesh (device 3) was placed into abdomen and anchored to fascia using sutures." on (b)(6) 2020 - patient was diagnosed with infected mesh, enterocutaneous fistula, ventral hernia thereby underwent open repair with the removal of meshes and implant of synthetic mesh.Per op notes, "there was an area of scarring and sinus tract formation just superior to the umbilicus.Mesh was encountered which appeared to be the prior two layer of ventralex mesh.Adhesion to the mesh was taken down.A small bowel was densely adherent to mesh and bowel was in communication with sinus tract was resected.All the three meshes (device 1, 2, 3) were excised from abdominal wall.Multiple hernias along the upper midline was noted.A synthetic mesh was placed in an onlay position to reduce infection 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.Note, the manufacturing date (15-dec-2017) is considered to be a best estimate.This emdr represents the ventralex mesh (device 3).An additional supplemental emdr and emdr were submitted to represent the composix kugel mesh (device 1 & 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 ; 8005566756
• MDR Report Key: 24845304
• Report Number: 1213643-2026-00470
• Device Sequence Number: 15659812
• Product Code: FTL
• UDI-Device Identifier: 00801741031496
• UDI-Public: (01)00801741031496(17)200228(10)HUBZ1971
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K101928
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 04/08/2026

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: 02/28/2020
• Device Catalogue Number: 5950009
• Device Lot Number: HUBZ1971
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2017
• 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: 62 YR
• Patient Sex: Female