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

Catalog Number 0112660

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

Patient Problems Death (1802); Injury (2348); Disability (2371)

Event Date 12/15/2017

Event Type  Death  

Manufacturer Narrative

At this time no conclusions can be made to what extent the bard/davol flat mesh device may have caused or contributed to the reported event.The attorney alleges the patient had additional surgery; however no details have been provided.No medical records, autopsy, or death certificate have been provided.A review of the manufacturing records was performed and found that the lot was manufactured to specification.The actual date of event is unknown, reported as "(b)(6) 2017"; therefore, we are using (b)(6) 2017 as date of event.Should additional information be provided a supplemental emdr will be submitted.Device evaluated by manufacturer? not returned.

Event Description

It is alleged by patient's attorney that on or about (b)(6) 2015, patient underwent surgery for repair of an incisional hernia.As alleged, a bard/davol flat sheet was implanted to repair the hernia defect.It is also alleged, by the patient's attorney that sometime in (b)(6) 2017, the patient underwent a further operation to repair the hernia.As a result, the patient was injured severely and permanently which ultimately led to his death.As reported, patient has suffered considerable physical pain and mental anguish.As alleged, patient suffered from chronic pain, as well as psychological stress and depression, which ultimately led to death.As reported, the patient had undergone further other forms of care and medical treatments.As alleged, patient ultimately passed away as a result of the injuries sustained from the alleged defective bard flat sheet.

• Brand Name: BARD FLAT MESH
• 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: donette slade ; 100 crossings blvd.; warwick, RI 02886 ; 8015652300
• MDR Report Key: 9088985
• MDR Text Key: 159219004
• Report Number: 1213643-2019-08988
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016516
• UDI-Public: (01)00801741016516
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PREAMENDMENT
• 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: 09/19/2019

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 Expiration Date: 07/28/2019
• Device Catalogue Number: 0112660
• Device Lot Number: HUYF1641
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/03/2019
• Initial Date FDA Received: 09/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2014
• 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; Disability