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 Incontinence (1928); Prolapse (2475)

Event Date 01/25/2012

Event Type  Injury  

Manufacturer Narrative

At this time no conclusions can be made.It is unknown to what extent the bard/davol bard flat mesh device may have caused or contributed to the events as alleged by the patient¿s attorney.Recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Based on the limited information provided at this time, no conclusions can be made.Should additional information be provided a supplemental emdr will be submitted.Not returned.

Event Description

Per information provided by the patient's attorney, medical records & product id page: on (b)(6) 2008: the patient was diagnosed with uterine prolapse, stress incontinence and underwent a supracervical abd hysterectomy, retropubic urethropexy, cystotomy repair and sacrocolpopexy with implant of a bard/davol flat mesh.On (b)(6) 2012: the patient was diagnosed with recurrent stress urinary incontinence, symptomatic rectocele and underwent a posterior repair with "polypropylene mesh" (non davol), perineorrhaphy, sacrospinous ligament fixation and tvt placement (non bard/davol).

• 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 ; 8015652300
• MDR Report Key: 9142543
• MDR Text Key: 161953311
• Report Number: 1213643-2019-09609
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016516
• UDI-Public: (01)00801741016516
• 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: 10/01/2019

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: 10/28/2012
• Device Catalogue Number: 0112660
• Device Lot Number: HURI1112
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/16/2019
• Initial Date FDA Received: 10/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2007
• 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): Other; Required Intervention
• Patient Age: 50 YR