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

Catalog Number UNKAA077

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

Patient Problems Death (1802); Injury (2348)

Event Type  Death  

Manufacturer Narrative

At this time no conclusions can be made. The patient's attorney alleges surgical intervention; however, no details have been provided. No medical records, autopsy, or death certificate have been provided. No lot number has been provided; therefore a review of the manufacturing records is not possible. Should additional information be provided a supplemental emdr will be submitted. Not returned.

Event Description

Attorney alleges that on (b)(6) 2006, the patient underwent surgery for implant of an unspecified bard/davol ventralex. It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device(s). As reported, the patient is making a claim for an adverse patient outcome against the bard/davol ventralex. As reported, the attorney alleges patient experienced emotional distress, the device was defective, and wrongful death.

• 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: tina stein ; 100 crossings blvd.; warwick, RI 02886 ; 8015652300
• MDR Report Key: 8642325
• MDR Text Key: 146124238
• Report Number: 1213643-2019-04335
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2019
• 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?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/15/2019
• 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: 05/24/2019 Patient Sequence Number: 1