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

Catalog Number 5950007

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

Patient Problems Foreign Body Reaction (1868); Inflammation (1932); Disability (2371)

Event Date 09/28/2015

Event Type  Injury  

Manufacturer Narrative

There is no connection that can be made at this time between the reported post-operative complications and any problem with the bard/davol device used to treat the patient. No medical records have been provided. The sample was not returned for evaluation, therefore we are unable to confirm the alleged condition of the implant. Based on the limited information provided at this time, no conclusions can be made. Inflammation and allergic reaction are known inherent risks of surgery and are identified in the adverse reaction section of the instructions-for-use as a possible complication. Should additional information be provided a supplemental emdr 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.

Event Description

The following was alleged by the patient's attorney: on (b)(6) 2013: the patient underwent surgery for repair of an incarcerated umbilical hernia. As reported, a bard/davol ventralex st hernia patch , reference number (b)(4), lot number huxd0590 was implanted to repair the hernia defect. On (b)(6) 2015: the patient underwent explant of the bard/davol ventralex st hernia patch. It is alleged that sometime after placement the device malfunctioned by, inter alia, contracting, suffering degradation, and causing an intense foreign body and inflammatory response. It is alleged that as a result of these failures, the patient has suffered severe injuries, required substantial medical care, has suffered and will continue to suffer physical pain.

• Brand Name: VENTRALEX ST
• 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: francesca santamaria ; 100 crossings blvd.; warwick, RI 02886 ; 4018258538
• MDR Report Key: 7152947
• MDR Text Key: 96005757
• Report Number: 1213643-2017-01128
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101928
• 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

• Device Expiration Date: 04/28/2015
• Device Catalogue Number: 5950007
• Device Lot Number: HUXD0590
• 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: 12/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2013
• 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