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

Model Number 0010301

Device Problems Defective Device (2588); Patient Device Interaction Problem (4001); Migration (4003)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Fistula (1862); Inflammation (1932); Pain (1994); Hernia (2240); Disability (2371); Bowel Perforation (2668)

Event Date 08/17/2016

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event.To date no medical records have been provided.Based on the information provided, it is alleged the patient experienced hernia recurrence.Recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.Not returned to manufacturer.

Event Description

The following was reported to davol by the patient's attorney: (b)(6) 2006 - the patient underwent surgery for repair of a ventral hernia, a ventralex hernia patch was implanted to repair the hernia defect.(b)(6) 2016 - the patient underwent an additional surgery to repair the hernia defect and remove the mesh.The attorney alleges the ventralex patch used in the patient's hernia repair surgery allegedly failed, resulting in much pain and suffering, doctor visits, subsequent procedure and was severely and permanently injured.

Event Description

The following was reported to davol by the patient's attorney: (b)(6) 2006 - the patient underwent surgery for repair of a ventral hernia, a ventralex hernia patch was implanted to repair the hernia defect.(b)(6) 2016 - the patient underwent an additional surgery to repair the hernia defect and remove the mesh.The attorney alleges the ventralex patch used in the patient's hernia repair surgery allegedly failed, resulting in much pain and suffering, doctor visits, subsequent procedure and was severely and permanently injured.Addendum per additional information provided: (b)(6) 2006 - patient was diagnosed with umbilical hernia thereby underwent open repair with the implant of ventralex mesh.Per operative notes, "the edges of the hernia were identified and freed up the umbilicus.A small ventralex hernia patch was placed inside the abdominal cavity and sutured." (b)(6) 2016 - patient had chronic abdominal pain and was diagnosed with recurrent incarcerated umbilical hernia thereby underwent repair with removal of the mesh.Per operative notes, "mesh was completely engulfed inside the lumen of the small bowel stuck to the umbilical region with extensive inflammation and fistulization then noticed to have a large inflammatory mass stuck to the umbilical side in the abdominal cavity.This was taken down along with the adhesions.It was noted that the entire ventralex mesh was inside the lumen and was resected along with the bowel.Defect was closed primary anastomosis." attorney alleges that the patient had adhesions, bowel obstruction, bowel removal, infection, mesh migration, hernia recurrence, pain and emotional injuries.

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event.To date no medical records have been provided.Based on the information provided, it is alleged the patient experienced hernia recurrence.Recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.Addendum: this supplemental emdr is submitted to document additional information provided.Based on the available information, there is no change to the initial determination, no conclusion can be made.Per the medical record review, post implant of ventralex mesh, patient was diagnosed with abdominal pain, hernia recurrence, adhesions, fistula, inflammation, bowel perforation and mesh migration thereby underwent repair with mesh removal.The adverse reaction section of the instructions-for-use, supplied with the device identifies adhesions and inflammation as possible complications.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.H3 other text : not returned.

• Brand Name: MESH ¿ VENTRALEX
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 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 ; 4018258495
• MDR Report Key: 7140217
• MDR Text Key: 95591491
• Report Number: 1213643-2017-01092
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741000355
• UDI-Public: (01)00801741000355
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2011
• Device Model Number: 0010301
• Device Catalogue Number: 0010301
• Device Lot Number: 43AQD510
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/04/2017
• Initial Date FDA Received: 12/21/2017
• Supplement Dates Manufacturer Received: 10/30/2023
• Supplement Dates FDA Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Required Intervention; Life Threatening
• Patient Age: 53 YR
• Patient Sex: Male