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

Catalog Number 0010301

Device Problems Defective Device (2588); Insufficient Information (3190)

Patient Problems Seroma (2069); Hernia (2240); Disability (2371)

Event Date 12/30/2016

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, recurrence, seroma, inflammation and surgical intervention. The instructions-for-use supplied with the device lists seroma 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) 2005, the patient underwent a repair of a supraumbilical hernia. A bard/davol ventralex mesh was implanted. On or about (b)(6) 2016, the patient underwent surgery to revise the failed ventralex mesh and a non-bard davol mesh was implanted during the procedure. On or about (b)(6) 2020, the patient underwent surgery to revise the failed mesh products. Attorney alleges that the patient experiences and/or continue to experience severe and chronic pain, inflammation, consistent bulging filled with fluid, recurrence, and tenderness. 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: 11379944
• MDR Text Key: 233760874
• Report Number: 1213643-2021-01310
• Device Sequence Number: 1
• Product Code: FTL
• 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: consumer,other

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/28/2010
• Device Catalogue Number: 0010301
• Device Lot Number: 43DPD415
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2005
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 02/25/2021 Patient Sequence Number: 1