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

Catalog Number	0010303
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Pain (1994); Constipation (3274)
Date of Event	02/07/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As alleged, post implant of a ventralex mesh using permasorb fixation in 2012 the patient has experienced adverse symptoms including pain and constipation.Based on the information provided, no conclusions can be made as to the degree to which the implant may be causing or contributing the patient¿s reported ongoing symptoms.A review of manufacturing records shows product was made to specification.To date, this is the only reported complaint for this lot of 190 units.Note, the date of event (07-feb-2012) is considered to be a best estimate.This mdr represents the ventralex mesh.An additional mdr was submitted to represent the permasorb fixation device.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, the patient presented with localized dehiscence at the umbilical ring, extending above and below the umbilicus thereby underwent umbilical hernia repair with implant of ventralex mesh using permasorb fixation device on (b)(6) 2012.It was reported that the postoperative course is uneventful, and the patient was discharged.Per information reported post implant the patient had abdominal cramps with deformation, pain after meals, irregular bowel movements, constant constipation, daily pain, especially during activity, pain in the navel, ribs, and caesarean section site.Patient can no longer return to work as a cleaner.

• 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: 22186314
• Report Number: 1213643-2025-00465
• Device Sequence Number: 8691062
• Product Code: FTL
• UDI-Device Identifier: 00801741016486
• UDI-Public: (01)00801741016486(17)160228(10)HUVB0458
• 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: 2012
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2025

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: 02/28/2016
• Device Catalogue Number: 0010303
• Device Lot Number: HUVB0458
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2011
• 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: 41 YR
• Patient Sex: Female
• Patient Weight: 46 KG