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

Model Number 0010301

Device Problems Defective Device (2588); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Adhesion(s) (1695); Pain (1994); Hernia (2240); Disability (2371)

Event Date 09/13/2010

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 recurrence repair and lysis of adhesions.It is unclear at this time if the alleged adhesions were to the mesh that was implanted in the patient.Recurrence and adhesion are known inherent risks of surgery and are identified in the adverse reaction section of the instructions-for-use.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.The information provided by bard 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 bard.

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 mesh was implanted to repair the hernia defect.On (b)(6) 2010 - the patient underwent an additional surgery for lysis of adhesions and recurrence repair.The attorney alleges the patient has suffered and will continue to suffer pain and was injured severely and permanently.

Manufacturer Narrative

Addendum to the previous report.This supplemental emdr is being sent to correct the date of manufacture for the ventralex mesh.A manufacturing review was performed which found that the device provided was manufactured to specification.With the current information available, no definitive conclusion can be made.If additional event and/or evaluation information is obtained, a follow up emdr will be submitted.Corrected fields: device manufacture date.

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 recurrence repair and lysis of adhesions.It is unclear at this time if the alleged adhesions were to the mesh that was implanted in the patient.Recurrence and adhesion are known inherent risks of surgery and are identified in the adverse reaction section of the instructions-for-use.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.Addendum#1: this supplemental emdr is being sent to correct the date of manufacture for the ventralex mesh.A manufacturing review was performed which found that the device provided was manufactured to specification.With the current information available, no definitive conclusion can be made.If additional event and/or evaluation information is obtained, a follow up emdr will be submitted.Addendum#2: this supplemental emdr is submitted to document additional information provided.Based on the additional information received, there is no change to the initial determination, no conclusions can be made.Per the medical records review, about 4 years 7 months post implant of ventralex mesh, patient had adhesions, hernia recurrence and pain thereby underwent repair.The instructions-for-use supplied with the device list pain as a possible complication.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.

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 mesh was implanted to repair the hernia defect.(b)(6) 2010 - the patient underwent an additional surgery for lysis of adhesions and recurrence repair.The attorney alleges the patient has suffered and will continue to suffer pain and was injured severely and permanently.Addendum per additional information provided: (b)(6) 2006 - patient was diagnosed with incarcerated ventral hernia thereby underwent open repair with the implant of ventralex mesh.Per operative notes, ¿herniated incarcerated portion of preperitoneal fat was dissected off the surrounding tissues and the ventralex mesh was then used with nonreactive side facing the preperitoneum and was attached circumferentially with sutures.¿ (b)(6) 2010 - patient was diagnosed with incarcerated incisional hernia, pain thereby underwent laparoscopic repair.Per operative notes, ¿extensive adhesiolysis was performed.Once completed, 3 defects were found, and a piece of synthetic mesh was secured at four quadrants using suture and the mesh was tacked.¿ (there is no mention/visualization of mesh in operative notes) attorney alleges that the patient had adhesions, pain, hernia recurrence and emotional injuries.

• 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: 7137683
• MDR Text Key: 95474350
• Report Number: 1213643-2017-01083
• 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,Followup
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2010
• Device Model Number: 0010301
• Device Catalogue Number: 0010301
• Device Lot Number: 43FPD621
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2005
• 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
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 90 KG