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

Catalog Number	0010301
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Adhesion(s) (1695); Nerve Damage (1979); Hernia (2240)
Date of Event	07/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2009 ¿ patient was diagnosed with umbilical hernia thereby underwent open repair with implant of ventralex mesh (device #2).Per operative notes, ¿the hernia sac was identified and reduced.A small ventralex mesh (device #2) was placed into the peritoneal cavity and secured using sutures.¿ attorney alleges that patient had nerve damage, hernia recurrence, adhesions, pain, bowel removal, emotional injuries.It also alleged that the patient had crohn¿s disease and mesh migration.Note: there is no operative notes provided for the composix e/x (device #1) implanted on (b)(6) 2006 in ppf and medical records.
Additional Manufacturer Narrative
Root cause is inconclusive; no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.Note, the manufacturing date (15-apr-2009) is considered to be a best estimate.Note, the date of event is considered to be a best estimate as ((b)(6) 2025) based on the date of awareness.This emdr represents the bard/davol ventralex mesh (device #2).An additional supplemental emdr was submitted to represent the bard/davol composix e/x (device #1).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: 22749044
• Report Number: 1213643-2025-00737
• Device Sequence Number: 9672835
• Product Code: FTL
• UDI-Device Identifier: 00801741000355
• UDI-Public: (01)00801741000355(17)140428(10)HUTD0904
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K132441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/08/2025

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: 04/28/2014
• Device Catalogue Number: 0010301
• Device Lot Number: HUTD0904
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2009
• 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: Disability
• Patient Age: 57 YR
• Patient Sex: Male