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

Catalog Number	0010302
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	10/17/2014
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 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.
Event or Problem Description
Per information provided: on (b)(6) 2010 - patient was diagnosed with incarcerated umbilical hernia thereby underwent open repair with implant of ventralex mesh (device 1).Per op notes, "a curvilinear incision was made around the upper portion of hernia sac.Removed the hernia sac from the fundus of the umbilicus, dissected out the incarcerated omentum.A ventralex mesh (device 1) was placed and secured with sutures." on (b)(6) 2014 - patient was diagnosed with incarcerated periumbilical hernia, adhesion thereby underwent open repair with implant of ventralex mesh (device 2).Per op notes, ¿an incision was made over the hernia site just to the left of the umbilicus.Dissected off the incarcerated omentum which was adherent to the wall of the sac.A ventralex mesh (device 2) was placed within the defect and was secured with sutures from the posterior side through the anterior mesh through the fascia and then through the strap." on (b)(6) 2014 - patient was diagnosed with chronically incarcerated recurrent ventral incisional hernia, adhesion, thereby underwent laparoscopic repair with implant of ventralight st using echo ps mesh (device 3).Per op notes, "an incision was made in the left subcostal region and enter the peritoneal cavity.The adhesions which were noted to be mostly omental tissues to the old mesh was taken down.Hernial defect was identified adjacent to the mesh.The defect was closed primarily.Then a of ventralight st using echo ps mesh (device 3) was placed to cover the defect and old mesh and was secured with the tacks to the anterior abdominal wall.".

• 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: 25659304
• Report Number: 1213643-2026-00813
• Device Sequence Number: 5765220
• Product Code: FTL
• UDI-Device Identifier: 00801741016479
• UDI-Public: (01)00801741016479(17)190328(10)HUYB1273
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: K021736
• 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): 06/25/2026

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: HUYB1273
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 06/29/2026
• 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: 61 YR
• Patient Sex: Male