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

Catalog Number 0010302

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

Patient Problems Pain (1994); Hernia (2240); Insufficient Information (4580)

Event Date 01/11/2019

Event Type  Injury  

Manufacturer Narrative

No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including disability, hernia recurrence and subsequent surgical intervention for mesh removal.The instructions-for-use (ifu) supplied with the device lists recurrence of the hernia as a possible complication.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Should additional information be provided, a supplemental emdr will be submitted.

Event Description

Attorney alleges that on or about (b)(6) 2015, the patient underwent umbilical hernia repair for the implant of two layers of bard ventralex hernia patch.It is alleged that on or about (b)(6) 2019, the patient underwent a second surgery to remove the mesh and repair a recurrence of the patient¿s hernia defect.Attorney alleges that the ventralex hernia patch implanted in patient failed to reasonably perform as intended.It is alleged that the product therefore had to be surgically removed necessitating further invasive surgery to repair the very issue that the product was intended to repair.Attorney alleges that the patient sustained severe personal injuries, pain and suffering, severe emotional distress, obligations for medical services and expenses, severe and permanent pain, disability and impairment.It is also alleged that the device was defective.

• 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: 13053838
• MDR Text Key: 285609179
• Report Number: 1213643-2021-09444
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016479
• UDI-Public: (01)00801741016479
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021736
• 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
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2018
• Device Catalogue Number: 0010302
• Device Lot Number: HUZD1398
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2015
• 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 Sex: Female