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

Catalog Number	0010301
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Pain (1994); Scar Tissue (2060); Hernia (2240)
Date of Event	02/08/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2005 - patient was diagnosed with incisional hernia thereby underwent laparoscopic repair with the implant of composix kugel mesh (device 1) and ventralex mesh (device 2).Per op notes, "a composix kugel mesh (device 1) was placed into the abdominal cavity through the left upper quadrant incision.A small ventralex mesh (device 2) was sutured to the fascia." (b)(6) 2009 - patient was diagnosed with recurrent ventral hernia and eventration of previous mesh thereby underwent laparoscopic repair with the implant of composix mesh (device 3).Per op notes, "the previous hernia repair omentum was adhered to the undersurface of the mesh.Adhesiolysis was carried out.A composix mesh (device 3) was placed into the abdominal cavity using tacks." (b)(6) 2014 - patient was diagnosed with perianal abscess thereby underwent incision and drainage of perianal abscess.Per op notes, "there was entrance into the abscess cavity, there was release of purulent fluid." (b)(6) 2016 - patient had pain and mass at previous ventral hernia site thereby underwent repair with removal of all the meshes (device 1, 2 and 3).Per op notes, "found to be dense adhesions, scar tissue, densely adhered to a layer of underlying mesh.This was then taken off of the mesh.The mesh (device 1, 2 and 3) were 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 mdr represents the ventralex mesh (device 2).An additional supplemental emdr was submitted to represent the composix mesh (device 3).An additional mdr was submitted to represent the composix kugel 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: 24321005
• Report Number: 1213643-2026-00112
• Device Sequence Number: 15821594
• Product Code: FTL
• UDI-Device Identifier: 00801741000355
• UDI-Public: (01)00801741000355(17)100628(10)43FPD424
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K132441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/02/2026

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: 06/28/2010
• Device Catalogue Number: 0010301
• Device Lot Number: 43FPD424
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 02/12/2026
• 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: 63 YR
• Patient Sex: Female