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

Catalog Number	0010303
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Unspecified Infection (1930)
Date of Event	07/05/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2009: patient was diagnosed with incarcerated umbilical and incisional hernia thereby underwent open repair with implant of ventralex mesh (device #1).Per operative notes, ¿hernia sac was dissected free from the umbilical region.Then a ventralex mesh (device #1) was placed in the preperitoneal space and tacked by sutures.¿ on (b)(6) 2009: patient was diagnosed with recurrent incisional hernia thereby underwent laparoscopic repair with the implant of ventrio mesh (device #2).Per operative notes, ¿previously placed ventralex mesh (device #1) was identified in good position, just right to this re-hernia is noted.A ventrio mesh (device #2) was placed into abdominal cavity and sutured.On (b)96) 2009: patient was diagnosed with recurrent incisional hernia thereby underwent open repair with the implant of ventralex mesh (device #3) and explant of ventralex mesh (device #1) and ventrio mesh (device #2).Per operative notes, ¿previously placed ventralex mesh (device #1) was removed as it found to be totally unattached to the left side of the rectus and the another previously placed ventrio mesh (device #2) was unincorporated and one area there was some buckling of the mesh allowing tunnelling from an area where the fixation tacks were loose.All adhesions were taken down.A large ventralex mesh (device #3) was placed and sutured.On (b)(6) 2009: patient was diagnosed with infection thereby underwent open repair with the implant of allomax (device #4) and explant of ventralex mesh (device #3).Per operative notes, ¿the ventralex mesh (device #3) was dissected free from the underside of the fascia and removed.Adhesions were taken down around the hernia and allomax mesh (device #4) was placed and secured by sutures.¿ attorney alleges that the patient had adhesion, infection, pain, hernia recurrence, pain, mesh migration and mesh shrinkage.It is also alleged that the first placed mesh was completely detached on one side resulting in recurrent hernia, second placed mesh was completely unincorporated allowing tunneling of omental fat up into the defect and resulting in a hernia recurrence, buckling of mesh allowing the lacks to come loose, wound vac placement.
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per medical records review, about 7 months post implant of ventralex mesh, patient was diagnosed with infection and adhesions thereby underwent repair with mesh removal.The instructions-for-use supplied with the device lists infection and adhesions as possible complication(s).In regards to infection the warning section of ifu states, "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the patch.An unresolved infection may require removal of the mesh." note, the manufacturing date (15-feb-2009) is considered to be a best estimate.This emdr represents the mesh ¿ ventralex (device #3).An additional supplemental emdr's were submitted to represent the mesh ¿ ventralex (device #1) and ventrio mesh (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: SUGICAL 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 ; 4018258495
• MDR Report Key: 21908081
• Report Number: 1213643-2025-090172
• Device Sequence Number: 4221290
• Product Code: FTL
• UDI-Device Identifier: 00801741016486
• UDI-Public: (01)00801741016486(17)140328(10)HUTB1468
• 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: 2009
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/25/2025

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 Expiration Date: 03/28/2014
• Device Catalogue Number: 0010303
• Device Lot Number: HUTB1468
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2009
• 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; Disability
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 100 KG