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

Catalog Number UNKAA030

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 to what extent the bard/davol flat mesh (device #1) may have caused or contributed to the reported event.No medical records, autopsy, or death certificate have been provided.The cause of the patient postoperative complications cannot be determined at this time.No lot number has been provided therefore a review of the manufacturing records is not possible at this time.Information is limited.Should additional information be provided a supplemental emdr will be submitted.This emdr represents the bard/davol flat mesh (device #1).An additional emdr was submitted to represent the bard/davol ventrio st (device #2).Not returned.

Event Description

Attorney alleges that on (b)(6) 2018, the patient underwent surgery for implant of an unspecified bard/davol bard mesh (device #1) and ventrio st (device #2).It is alleged that on an unspecified date, the patient passed away.As reported, the patient is making a claim for an adverse patient outcome against the bard mesh (device #1) and ventrio st (device #2).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: 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: jan ling ; 100 crossings blvd.; warwick, RI 02886 ; 8015652663
• MDR Report Key: 8709055
• MDR Text Key: 148335612
• Report Number: 1213643-2019-05170
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA030
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/06/2019
• 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