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 Adhesion(s) (1695); Inflammation (1932); Pain (1994); Hernia (2240); Insufficient Information (4580)

Event Date 05/30/2014

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 permanent injury, hernia recurrence, adhesions, inflammation and revision surgery.The instructions-for-use (ifu) supplied with the device lists hernia recurrence, adhesions, pain as possible complications.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.Not returned.

Event Description

Attorney alleges on or about (b)(6) 2012, the patient underwent repair of a left lower quadrant hernia during which a bard/davol ventralex mesh was implanted.It is alleged that on or about (b)(6) 2014, the patient underwent an additional left lower quadrant hernia surgery during which a non-bard/davol physiomesh was implanted.It is alleged that on or about (b)(6) 2017, the patient underwent revision surgery.Attorney alleged that the patient experienced and/or continues to experience severe and chronic pain/discomfort, inflammation, recurrence, adhesions, and adhesions to the mesh.The ventralex mesh caused serious injury and had to be surgically removed via invasive surgery and necessitated additional invasive surgery to repair the hernia.It is also alleged that the patient has suffered and will continue to suffer physical pain and suffering, as well as mental anguish, permanent and severe scarring and disfigurement and had emotional distress, sustained severe and permanent pain, suffering, disability and impairment.Attorney also alleges past, present, and future damages, including but not limited to, pain and suffering for severe and permanent personal injuries sustained by the patient and permanent 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: 15630125
• MDR Text Key: 301979677
• Report Number: 1213643-2022-96751
• 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: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2016
• Device Catalogue Number: 0010302
• Device Lot Number: HUVD0029
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2011
• 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