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

Catalog Number	0010303
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001); Migration (4003)
Health Effect - Clinical Codes	Adhesion(s) (1695); Scar Tissue (2060); Hernia (2240); Obstruction/Occlusion (2422); Fibrosis (3167)
Date of Event	10/14/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2013: patient was diagnosed with recurrent upper midline hernia thereby underwent open repair with implant of ventralex mesh (device #1).Per operative notes,¿ at the level of fascia, the hernia sac was excised.A ventralex mesh (device #1) was inserted into the subfascial position and sutured." on (b)(6) 2015: patient was diagnosed with recurrent incisional midline ventral hernia thereby underwent open repair with implant of sepramesh ip (device #2).Per operative notes, "the hernia sac was scarred and fibrotic.The hernia contents were excised from the sac.The adhesions in the entire length of the mesh and lateral sidewall was freed.A sepramesh ip (device #2) of approximate size was placed and sutured." on (b)(6) 2016: patient was diagnosed with recurrent incisional hernia and intestinal obstruction thereby underwent open repair with implant of ventrio st mesh (device #3).And removal of mesh (device #1 and #2).Per operative notes, ¿to the hernia sac two piece of previously placed mesh was detached from the left side of the fascia.The single loop of small intestine adherent to the old mesh caused small bowel obstruction.The lysis of adhesions was undertaken between bowel from old mesh and omentum from hernia sac.The mesh (device #1 and #2) was separated from the fascia and explanted.A ventrio st mesh (device #3) was secured in place and sutured." attorney alleges that the patient had adhesions, pain, hernia recurrence and emotional injuries.
Additional Manufacturer Narrative
Based on the information received, no conclusions can be made.Per medical records review, about 3 years 3 months post implant of ventralex mesh, patient was diagnosed with adhesions, obstruction, fibrosis, scar tissue, mesh migration and hernia recurrence thereby underwent repair with mesh removal.The instructions-for-use supplied with the device lists adhesions, mesh migration and hernia recurrence as possible complications.Review of manufacturing records confirms product was manufactured to specification.Note, the manufacturing date (15-sep-2010) is considered to be a best estimate.This emdr represents the bard/davol mesh ¿ ventralex (device #1).An additional supplemental emdr was submitted to represent the bard/davol sepramesh ip (device #2).Note: section a through f - the information provided by bard 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 bard.

• Brand Name: MESH ¿ VENTRALEX
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 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: 21906917
• Report Number: 1213643-2025-090170
• Device Sequence Number: 4183898
• Product Code: FTL
• UDI-Device Identifier: 00801741016486
• UDI-Public: (01)00801741016486(17)151028(10)HUUI2369
• 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: 2013
• 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): 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: 10/28/2015
• Device Catalogue Number: 0010303
• Device Lot Number: HUUI2369
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2010
• 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: 68 YR
• Patient Sex: Female