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

Catalog Number	0010302G
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The degree to which the ventralex mesh implant used to treat the patient, may be causing, or contributing to the ongoing symptoms is unknown.Based on the information provided a definitive cause for the reported chronic pain in the region cannot be determined.Pain is listed as a possible complication in the adverse reaction section of the instructions-for-use, provided with the device.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represents the ventralex mesh (device #4).Additional emdr' s were submitted to represent the 3dmax mesh (device #1), 3dmax mesh (device #2) and ventralex mesh (device #3).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
As reported per ansm report (b)(4) in summary: on (b)(6) 2017 ¿ patient underwent bilateral inguinal hernia repair by laparoscopy with the insertion of a 3d prosthesis (bd/bard 3dmax mesh device #1 and device #2) and resorbable staples.Patient had persistent left groin and umbilical pain, swelling and constipation.On (b)(6) 2017 - ultrasound showed persistence of a small, vaguely inflamed scar in the periumbilical region, it appears that the left inguinal mesh has been displaced and is now in a vertical oblique position with fluid collection around it, causing the clinical impression of a painful swelling.On (b)(6) 2017 - patient was diagnosed with recurrent bilateral inguinal hernia because hyper-pressure mobilized the previous prostheses, resulting in an external oblique recurrence.Following dissection of the hernia sac and epigastric vessels, the original prosthesis (3d) was reinserted and ventralex mesh was implanted around the recurrence sac and sutured.The same procedure was performed on the both sides (bd/bard ventralex mesh device #3 and device #4).On (b)(6) 2017 - cortisone injection provided to manage chronic pain.On (b)(6) 2017 - ct - small, asymptomatic umbilical hernia.On (b)(6) 2017 - us no hernia recurrence.On (b)(6) 2017 - cortisone injection provided to manage chronic pain.On (b)(6) 2017 - patient had a gynaecological follow-up and noted persistent pain in the inguinal region.The surgeon noted two hardened cords which, when palpated, reproduce the pain felt by the patient, possibly due to prosthetic retraction.On (b)(6) 2018 - patient was started on lyrica for pain.On (b)(6) 2018 - inguinal us - no hernia recurrence.Slightly irregular appearance of the left hernial orifice with slightly thickened prosthetic material.Current condition of the patient: persistent and chronic pain to date, causing difficulties at work, in daily life and psychologically (depression).Stopped playing sport in his fifties: any abdominal effort (light physical exercise), light jogging, causes intense pain in the pubic area.The psychological consequences are sport, which was a stress reliever and made me feel good, is no longer possible.Consequences on weight: difficulty maintaining a stable weight.Consequences on the back: no more weight training to maintain the spine.Actions taken in the healthcare facility to treat the patient: nr.This report represents the ventralex mesh (device #4) implanted on the right side.

• 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: 22440574
• Report Number: 1213643-2025-00592
• Device Sequence Number: 16931806
• Product Code: FTL
• UDI-Device Identifier: 00801741016479
• UDI-Public: (01)00801741016479
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K132441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2025

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: 0010302G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 07/08/2025
• 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: 45 YR
• Patient Sex: Female
• Patient Weight: 60 KG