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	01/06/2012
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2006 - patient was diagnosed with symptomatic incisional hernias thereby underwent open repair with the implant of ventralex mesh (device # 1) and composix kugel mesh (device # 2).Per operative notes, "the total defect was noted and the hernia had extruded and the contents were reduced.A ventralex mesh (device # 1) was placed and sutured.A composix kugel mesh (device # 2) was placed against anterior abdominal wall was sewn in place and sutured." on (b)(6) 2009 - patient was diagnosed with extensive adhesions thereby underwent lysis of adhesions and re-tack in one corner of previous mesh.On (b)(6) 2012 - patient was diagnosed with recurrent ventral hernia, right indirect inguinal hernia and right lower quadrant pain thereby underwent removal of mesh.Per operative notes, "the scar was excised.The underlying ventral hernia mesh (device #1) was removed.The ventral hernia mesh (device # 2) in lower midline was folded on left side inferiorly.Most of the mesh was removed.The upper one-third of mesh was left in place.Adhesions were taken down.The right indirect inguinal hernia was repaired using sutures." on (b)(6) 2015 - patient was diagnosed with multiple recurrent ventral incisional hernias and pain thereby underwent laparoscopic repair with implant of ventralight st mesh (device # 3) and removal of mesh.Per operative notes, "adhesions to the anterior abdominal wall in left lower quadrant was taken down.Two midline hernias towards the upper portion of infraumbilical region was reduced.A ventralight st mesh (device #3) was placed and tacked.A mesh (device # 2) was removed.".
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.This emdr represents the bard mesh ventralex (device # 1).An additional supplemental emdr was submitted to represent the bard mesh composix kugel (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 ; 8005566756
• MDR Report Key: 22196596
• Report Number: 1213643-2025-00473
• Device Sequence Number: 9275052
• Product Code: FTL
• UDI-Device Identifier: 00801741016479
• UDI-Public: (01)00801741016479(10)43EPD443
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K132441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/06/2025

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 Catalogue Number: 0010302
• Device Lot Number: 43EPD443
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 36 YR
• Patient Sex: Female