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 conclusion can be made to what extent the device may have caused or contributed to the reported event.With no lot number provided a review of the manufacturing records could not be conducted.At this time no details have been provided related to the cause of death.Should additional information be provided, a supplemental emdr will be submitted.Not returned to manufacturer.

Event Description

The following was reported to bd by the patient's attorney: on (b)(6) 2016, the patient underwent surgery for implant of an unspecified ventralex hernia patch.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.The patient's attorney alleges wrongful death and that the product is defective and the patient experienced emotional distress.

• 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: 8395541
• MDR Text Key: 137988048
• Report Number: 1213643-2019-01315
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132441
• 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: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA077
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/13/2019
• Initial Date FDA Received: 03/06/2019
• 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 Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention