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

Catalog Number	0010301
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Pain (1994); Peritonitis (2252)
Date of Event	10/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As per ansm report ((b)(4)): description of incident: since (b)(6) 2022, i have been living in hell.It started on (b)(6) 22 when i had surgery for an umbilical hernia.The surgeon inserted a ventralex prosthesis, which was poorly fitted and broke in my peritoneum, causing me to develop peritonitis.I have had multiple operations, and this is still the case today, the last one being on (b)(6) 25, but i am still in pain and there has been no improvement.Date of operation: (b)(6) 2025 clinical history: 45-year-old female patient.She presents with a hernia that has become bothersome.There is a clear indication for hernia repair.Approach: direct approach.Lesions observed: a note indicates a double hernia at the upper part of the scar.Upon opening the hernial neck, an incarcerated omental fringe is observed at this level, which will be resected.The neck is supra-centimetric, requiring the placement of a prosthesis.Procedure performed: release of the anterior aponeurosis of the rectus abdominis muscles.Dissection of the hernial neck, which is opened.A fringe of omentum is released at this level, which will be resected by ligation and sectioning with vicryl 2/0 and sent for histological examination.Haemostasis is checked.The intra-abdominal surfaces of the wall are released.A 4.3 cm ventralex prosthesis is inserted and its correct positioning and spreading are checked.Aponeurotic closure using the two strips of the prosthesis with ethibond 2/0.Closure of the anterior aponeuroses with stratafix 0.Subcutaneous closure with vicryl 3/0 and intradermal suture on the skin with monocryl 4/0.Current condition of the patient: i am in a situation where i have lost my job.I was a childminder and i will never be able to carry heavy things again.I am in constant pain and have been taking oxycontin every day for a year and a half".
Additional Manufacturer Narrative
As reported, the patient experienced peritonitis and pain post implant of ventralex mesh.Contact information was not provided as such we are unable to request additional information.Based on the information available to date, no conclusions can be made as to the degree to which the implant may have caused or contributed to the patient's postoperative complications.The adverse reaction section of the instructions-for-use, supplied with the device identifies pain as a possible complication.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Based on the information as provided the date of implant is not clear as such the date of implant field has been left blank.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: 24211878
• Report Number: 1213643-2026-00068
• Device Sequence Number: 9624675
• Product Code: FTL
• UDI-Device Identifier: 00801741000355
• UDI-Public: (01)00801741000355
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K132441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/16/2026

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 Catalogue Number: 0010301
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 01/29/2026
• 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 Sex: Female
• Patient Weight: 81 KG