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

Catalog Number	0010302
Medical Device Problem Codes	Material Deformation (2976); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/22/2015
Type of Reportable Event	Serious Injury
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-feb-2014) is considered to be a best estimate.This supplemental emdr represents the mesh-ventralex (device 2).An additional supplemental emdr was submitted to represent the bard/davol mesh -ventralex (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.
Event or Problem Description
Per information provided: on (b)(6) 2014 ¿ patient was diagnosed with symptomatic reducible right inguinal hernia and umbilical hernia thereby underwent laparoscopic repair with the implant of ventralex patch (device 1) on right inguinal and open repair with the implant of ventralex patch (device 2) on umbilicus.Per op notes, ¿a reducible fascial defect in the right inguinal region was noted.The defect was repaired with a ventralex patch (device 1) and secured using the tacks.Attention to the umbilicus hernia, a medium ventralex patch (device 2) was secured in subfascial fashion using sutures.¿ on (b)(6) 2015 ¿ patient was diagnosed with recurrent right inguinal hernia thereby underwent laparoscopic repair with the implant of bard flat mesh (device 3).Per op notes, ¿the right inguinal hernia had some omental adhesions to mesh was taken down.The mesh to be high on the abdominal wall and with incomplete closure over the defect.The mesh being easily lifted up to show the hernia and cooper's ligament down below the area where the mesh (device 1) was present.Attempted to do a preperitoneal repair with placement of a balloon in the preperitoneal space but upon trying to dissect out where the mesh was, the peritoneum tore.The peritoneum was tacked up over the mesh with tacks.The mesh pulling free at umbilical repair site.Several tacks were used to reinforce the edges of umbilical mesh (device 2) which were folded down.The right inguinal hernia sac was found.A piece of bard flat mesh (device 3) was placed and the fascia tacked at shelving edge of ilioinguinal ligament.¿.

• 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: 23943284
• Report Number: 1213643-2026-00001
• Device Sequence Number: 21513921
• Product Code: FTL
• UDI-Device Identifier: 00801741016479
• UDI-Public: (01)00801741016479(17)190328(10)HUYB1272
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K132441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/02/2026

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: 03/28/2019
• Device Catalogue Number: 0010302
• Device Lot Number: HUYB1272
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2014
• 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: 28 YR
• Patient Sex: Female