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

Catalog Number	0010301
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Adhesion(s) (1695)
Date of Event	07/07/2010
Type of Reportable Event	Serious Injury
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 mesh - ventralex (device #3).Additional supplemental emdrs were submitted to represent the bard flat mesh (device #1) and bard mesh - composix e/x (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.
Event or Problem Description
Per information provided: (b)(6) 2002 ¿ patient was diagnosed with abdominal incisional hernia thereby underwent open repair with the implant of bard flat mesh (device #1).Per op notes, ¿the hernia in midline and lower sternotomy incision was noted.The bard flat mesh (device #1) was placed on the defect and secured using sutures circumferentially.¿ (b)(6) 2003 ¿ patient was diagnosed with recurrent incisional hernia and umbilical hernia thereby underwent laparoscopic repair with the implant of composix e/x mesh (device #2) and ventralex patch (device #3).Per op notes, ¿recurrent hernia was just inferior to the xiphoid process which had some incarcerated omentum.A piece of composix e/x mesh (device #2) was placed within abdomen and tacked.The ventralex patch (device #3) was placed through the umbilical defect and secured using sutures.¿ (b)(6) 2010 ¿ patient was diagnosed with recurrent and incarcerated incisional hernia at epigastrium thereby underwent laparoscopic repair with the partial removal of meshes (device #1, 2).Per op notes, ¿the adhesions around umbilicus and epigastrium were taken down.The liver was also adhered to the previous mesh (device #3) and was freed from the mesh.Both the meshes (device #1, #2) were retracted and pulled away at inferior portion of recurrent hernia.Part of the old mesh (device #1, #2) were excised and removed.A synthetic mesh was placed intraabdominally to cover the defect and sutured.¿ (b)(6) 2011 ¿ patient underwent laparoscopic terminal ileum and right colon resection and cyst excision.(b)(6) 2011 ¿ patient was diagnosed with right lower quadrant incarcerated incisional hernia thereby underwent laparoscopic repair with implant of synthetic mesh.(b)(6) 2012 ¿ patient was diagnosed with recurrent right flank hernia thereby underwent open repair with the implant of ventrio patch (device #4).Per op notes, ¿the synthetic mesh was peeled off from anterior abdominal wall, which was adherent to omentum.A ventrio patch (device #4) was placed to cover the entire defect and secured using tackers.¿.

• 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: 22458271
• Report Number: 1213643-2025-00601
• Device Sequence Number: 8252268
• Product Code: FTL
• UDI-Device Identifier: 00801741000355
• UDI-Public: (01)00801741000355(10)43JND273
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K132441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/20/2025

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: 0010301
• Device Lot Number: 43JND273
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 07/09/2025
• 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: 60 YR
• Patient Sex: Male