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

Catalog Number UNKAA077

Device Problems Defective Device (2588); Folded (2630); Material Deformation (2976)

Patient Problems Adhesion(s) (1695); Pain (1994); Disability (2371)

Event Date 08/07/2014

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event. To date no medical records have been provided. Based on the information provided, it is alleged the patient experienced material deformation, folded mesh and adhesions. Adhesions is a known inherent risk of surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication. Without the device sample returned for evaluation, the allegation of material deformation and folded mesh can not be assessed at this time. If additional event and/or evaluation information is obtained, a follow up mdr will be submitted. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. Not returned to manufacturer.

Event Description

The following was reported to davol by the patient's attorney: (b)(6) 2011 - the patient underwent surgery for repair of ventral incisional hernia, a ventralex hernia patch was implanted to repair the hernia defect. (b)(6) 2014 - the patient underwent an additional surgery when a ct scan revealed the mesh had contracted and folded. (b)(6) 2015 - the patient had to undergo another procedure for repair of the folded mesh and multiple adhesions adherent to the mesh. The attorney alleges the patient has suffered and will continue to suffer physical pain and was severely and permanently injured.

• 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: 7043227
• MDR Text Key: 92467326
• Report Number: 1213643-2017-00891
• 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: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNKAA077
• 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: 10/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 11/17/2017 Patient Sequence Number: 1