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); Disability (2371)

Event Date 05/01/2017

Event Type  Death  

Manufacturer Narrative

At this time no conclusions can be made.No lot number has been provided therefore a review of the manufacturing records is not possible.No medical records, autopsy, or death certificate have been provided.Information is limited at this time.Should additional information be provided a supplemental emdr will be submitted.Not returned.

Event Description

Attorney alleges that on (b)(6) 2008, the patient underwent surgery for implant of an unspecified bard/davol ventralex.It is alleged that on (b)(6) 2017, the patient passed away.As reported, the patient is making a claim for an adverse patient outcome against the ventralex.As reported, the attorney alleges wrongful death and general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient.".

• 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: roxanne tidwell ; 100 crossings blvd.; warwick, RI 02886 ; 8015652300
• MDR Report Key: 8633159
• MDR Text Key: 145834835
• Report Number: 1213643-2019-04200
• 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: 05/22/2019

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: 05/01/2019
• Initial Date FDA Received: 05/22/2019
• 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; Disability