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); Pain (1994); Hernia (2240)
Date of Event	08/30/2011
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 bard/davol mesh - ventralex (device 2).An additional supplemental emdr was submitted to represent the bard/davol mesh - ventralex (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.
Event or Problem Description
Per information provided: (b)(6) 2007 - patient was diagnosed with four incisional hernias thereby underwent open repair with implant of ventralex mesh (device 1 ¿ right and device 2 ¿ left).Per operative notes, ¿the two areas of palpable hernias which were at the colostomy site on the left and on the right side on the midline hernia.A vertical incision was made sharply through the old scar.On the left side was a very large, incarcerated hernia which was dissected out.A ventralex mesh (device 1) was placed into the left abdominal wall and secure it with sutures.On the right side the hernia sac was dissected out.A large ventralex mesh (device 2) was placed into right abdominal wall and secure it with sutures.¿ (b)(6) 2011 - patient was diagnosed with recurrent incisional hernia, adhesion, pain, thereby underwent open repair with implant of sepramesh ip (device 3) and explant of ventralex mesh (device 1 and device 2).Per operative notes, ¿prior surgical incision was excised.The hernia sac was dissected out.All adhesions were taken down.Prior placed ventralex mesh (device 1 ¿ right and device 2 ¿ left) was excised totally.A large sepramesh ip (device 3) was placed into anterior abdominal wall and secure it with sutures.¿.

• 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: 23941988
• Report Number: 1213643-2025-01297
• Device Sequence Number: 13432988
• Product Code: FTL
• UDI-Device Identifier: 00801741016479
• UDI-Public: (01)00801741016479(10)43LQD400
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K132441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/31/2025

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: 43LQD400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 01/02/2026
• 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: 58 YR
• Patient Sex: Female