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

Catalog Number	0010302
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	07/28/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
Per additional information provided: on (b)(6) 2009 - patient was diagnosed with large umbilical hernia thereby underwent open repair with the implant of ventralex mesh (device #1 & #2).Per operative notes, ¿hernia was identified.A ventralex mesh (device #1 & #2) was used for repair and secured by sutures.¿ on (b)(6) 2014 - patient was diagnosed with recurrent umbilical hernia and left inguinal hernia thereby underwent open repair with the implant of ventralex st (device #3) and bard flat mesh (device #4) and explant of ventralex mesh (device #1 & #2).Per operative notes, ¿previously placed ventralex mesh (device #1 & #2) were noted to be curled upon itself superiorly where the herniation had recurred and these meshes were removed.The incarcerated omentum was reduced, and hernia sac was excised.Then a ventralex st (device #3) was placed in the abdominal cavity and secured by sutures.Then the attention turned to the left inguinal region, once the external ring was identified, the cord structures were dissected out.Then a bard flat mesh (device #4) was placed around the spermatic cord with the apex at the pubic tubercle using sutures.¿.
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-mar-2009) is considered to be a best estimate.This emdr represents the ventralex mesh (device #2).An additional supplemental emdr was submitted to represent the ventralex mesh(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: 22193150
• Report Number: 1213643-2025-00470
• Device Sequence Number: 8628300
• Product Code: FTL
• UDI-Device Identifier: 00801741016479
• UDI-Public: (01)00801741016479(17)140428(10)HUTC1374
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K132441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/04/2025

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: 0010302
• Device Lot Number: HUTC1374
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2009
• 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: Required Intervention
• Patient Age: 41 YR
• Patient Sex: Male