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

Event Date 11/18/2015

Event Type  Injury  

Manufacturer Narrative

Based on the information provided we are unable to determine to what extent, if any the bard device may have caused or contributed to the events as alleged by the patient¿s attorney. The information provided alleges that the, patient underwent an additional surgery to repair an incarcerated recurrent hernia defect, release adhesions between the patient's bowel and the ventralex mesh, and "remove it. " medical records were not provided and the description does not clearly define what "remove it" is referring to (example possible mesh explant, partial explant, or removal/repair of the hernia defect itself without explant of previously placed mesh). As such at this time, we have not identified this as reported device explant. Adhesions and recurrence are known inherent risks of surgery and are identified in the adverse reaction section of the instructions-for-use as a possible complications. 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. Not returned.

Event Description

The following was alleged by the patient's attorney: on (b)(6) 2011: the patient underwent surgery for repair of a ventral hernia. As reported, a bard/davol ventralex hernia patch, reference number 0010301, lot number hutj0629 was implanted to repair the hernia defect. On (b)(6) 2015: the patient underwent an additional surgery to repair an incarcerated recurrent hernia defect, release adhesions between the patient's bowel and the ventralex mesh, and "remove it. " as alleged, the patient was injured severely and permanently and has suffered and will continue to suffer physical pain due to the alleged defective ventralex hernia patch.

• 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: francesca santamaria ; 100 crossings blvd.; warwick, RI 02886 ; 4018258538
• MDR Report Key: 7152262
• MDR Text Key: 95966837
• Report Number: 1213643-2017-01126
• 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: 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: 11/28/2014
• Device Catalogue Number: 0010301
• Device Lot Number: HUTJ0629
• 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: 12/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2009
• 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