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

Catalog Number	0010303
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Pain (1994); Hernia (2240)
Date of Event	09/26/2011
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2006 - patient was diagnosed with incarcerated ventral hernia thereby underwent open repair with the implant of bard flat mesh (device #1).Per op notes, "a midline incision was made above the umbilicus, a bard flat mesh (device #1) was placed using tacks." (b)(6) 2010 - patient was diagnosed with incarcerated supraumbilical hernia and recurrent epigastric hernia thereby underwent open repair with removal of mesh (device #1) and implant of ventralex mesh (device #2).Per op notes, "a portion of the mesh (device #1) was removed and a ventralex mesh (device #2) was placed into the umbilicus using sutures." (b)(6) 2011 - patient was diagnosed with recurrent ventral incisional hernia thereby underwent open repair with the implant of composix lp mesh (device #3).Per op notes, "a midline incision was made just above the umbilicus, a composix lp mesh (device #3) was secured to the peritoneum.".
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-nov-2009) is considered to be a best estimate.This emdr represents the ventralex mesh (device #2).An additional supplemental emdr was submitted to represent the bard flat 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: 22685401
• Report Number: 1213643-2025-00709
• Device Sequence Number: 8936930
• Product Code: FTL
• UDI-Device Identifier: 00801741016486
• UDI-Public: (01)00801741016486(10)HUTK1050
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K132441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2025

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: 0010303
• Device Lot Number: HUTK1050
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2009
• 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