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

Catalog Number	0010303
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	02/06/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2011 ¿ patient was diagnosed with four ventral hernias thereby underwent open repair with the implant of ventralex meshes (device 1, 2).Per op notes, ¿two separate hernias were encountered at the superior end of previous midline incision.A ventralex mesh (device 1) was placed through hernia and secured underside to the muscle using suture.Another two hernias were found inferior end of the previous incision.A ventralex mesh (device 2) was placed into defect and sutured.¿ (b)(6) 2012 ¿ patient underwent esophagogastroduodenoscopy.(b)(6) 2013 ¿ patient was diagnosed with four separate ventral hernias thereby underwent laparoscopic repair with the removal of meshes (device 1, 2).Per op notes, ¿significantly folded and convoluted mesh (device 2) at the mid portion of the abdomen and the second folded and convoluted scarred in mesh (device 1) up in the epigastrium with some obvious hernias in close proximity to meshes were noted.The mesh itself had folded and was not completely covering the initial intended hernia sites.Both the meshes (device 1, 2) were removed.The hernia was noted.A synthetic mesh was placed into abdominal cavity and sutured.¿.
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-2008) is considered to be a best estimate.This mdr 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: 24320472
• Report Number: 1213643-2026-00109
• Device Sequence Number: 15833491
• Product Code: FTL
• UDI-Device Identifier: 00801741016486
• UDI-Public: (01)00801741016486(17)130428(10)HUSD0797
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K132441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/02/2026

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 Expiration Date: 04/28/2013
• Device Catalogue Number: 0010303
• Device Lot Number: HUSD0797
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2008
• 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: 40 YR
• Patient Sex: Female