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

Catalog Number 0112680

Device Problem Defective Device (2588)

Patient Problem Prolapse (2475)

Event Date 04/21/2006

Event Type  Injury  

Manufacturer Narrative

At this time no conclusions can be made.The patient's attorney did allege the patient was diagnosed with symptomatic cystocele and underwent an anterior repair, however, no details have been provided regarding the nature of the injury.A review of the manufacturing records is not possible.No direct allegation was made against the bard flat mesh and it is unclear if the secondary intervention was a revision or involved as there is no indication of the visualization of the bard flat mesh.Should additional information be provided a supplemental emdr will be submitted.Not returned.

Event Description

Per legal claim and medical records: (b)(6) 1997: the patient was diagnosed with a vaginal vault prolapse and underwent a sacrocolpopexy with implant of a bard/davol bard flat mesh.(b)(6) 2006: the patient was diagnosed with symptomatic cystocele and underwent an anterior repair with implant of a non davol "pelvisoft" mesh.

• 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: roxanne tidwell ; 100 crossings blvd.; warwick, RI 02886 ; 8015652659
• MDR Report Key: 8038757
• MDR Text Key: 126149799
• Report Number: 1213643-2018-03859
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016530
• UDI-Public: (01)00801741016530
• 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: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0112680
• Device Lot Number: 881600
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2018
• 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): Required Intervention
• Patient Age: 63 YR