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

Model Number 0010302

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

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

Event Date 08/11/2010

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event. Based on the information provided, it is alleged the patient experienced hernia recurrence and adhesions. Both recurrence and adhesions are known inherent risks of hernia repair surgery and are identified in the adverse reaction section of the instructions-for-use as a possible complication. If additional event and/or evaluation information is obtained, a follow up mdr will be submitted. This file represents the ventralex (device #1) implanted in (b)(6) 2010. A second emdr has been submitted to address the other ventralex mesh (device #2) implanted in (b)(6) 2010. Not returned to manufacturer.

Event Description

The following was reported to davol by the patient's attorney: (b)(6) 2010 - the patient underwent surgery for repair of a ventral hernia, a bard ventralex mesh, (b)(4) and lot number hutl0021 (device #1) was implanted to repair the hernia defect. (b)(6) 2010 - the patient underwent an additional surgery to repair the recurrent hernia defect and take down adhesions that had formed. A ventralex mesh, (b)(4) and lot number huub0353 (device #2) was implanted to repair the hernia defect. (b)(6) 2015 - the patient underwent an additional surgery to repair the hernia defect, take down adhesions, and remove portions of the old mesh. During this procedure a sepramesh was implanted. The attorney alleges the patient has suffered and will continue to suffer pain and was injured severely and permanently.

• Brand Name: 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: steven figueroa ; 100 crossings blvd.; warwick, RI 02886 ; 4018258460
• MDR Report Key: 7150611
• MDR Text Key: 95905656
• Report Number: 1213643-2017-01111
• Device Sequence Number: 1
• Product Code: FTL
• 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: ATTORNEY
• Type of Report: Initial
• Report Date: 12/28/2017

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 12/28/2017
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 12/28/2014
• Device MODEL Number: 0010302
• Device Catalogue Number: 0010302
• Device LOT Number: HUTL0021
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/04/2017
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 12/15/2009
• 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: 12/28/2017 Patient Sequence Number: 1