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

Catalog Number 0010303

Device Problems Defective Device (2588); Detachment of Device or Device Component (2907); Material Deformation (2976)

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

Event Date 08/29/2013

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, mesh detachment, coiling, hernia recurrence, adhesions and inflammation.The instructions-for-use supplied with the device lists hernia recurrence, adhesions, and inflammation 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 that on or about (b)(6) 2013, the patient underwent repair of a ventral hernia and a bard/davol ventralex mesh patch was implanted to repair the hernia defect.The patient underwent revision surgery on or about (b)(6) 2013.It is alleged that on or about (b)(6) 2014, the patient underwent an additional revision surgery and a non-bard/davol mesh was implanted during the procedure.The patient underwent further revision surgery of the mesh products on or about (b)(6) 2016.Attorney also alleges that the patient experienced and/or continues to experience severe and chronic pain/discomfort, inflammation, mesh detachment, recurrence, dense adhesions and mesh coiling.Attorney alleges general allegations for ¿past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." 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: 11374416
• MDR Text Key: 233465644
• Report Number: 1213643-2021-01197
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016486
• UDI-Public: (01)00801741016486
• 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: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/24/2021

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: 01/28/2018
• Device Catalogue Number: 0010303
• Device Lot Number: HUXA0678
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/04/2021
• Initial Date FDA Received: 02/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2013
• 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): Required Intervention; Disability