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

Catalog Number 0112680

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

Patient Problems Erosion (1750); Fistula (1862); Abnormal Vaginal Discharge (2123)

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown whether the device may have caused or contributed to the reported event.Based on a review of medical records, the patient experienced discharge, erosion and fistula formation.Fistula formation is listed as a known possible adverse reaction in the instructions-for-use.It was further reported that there was erosion of implanted vaginal mesh.There is no information that would identify the exact mesh that was eroded, as the patient has a history of multiple implants; however, it appears, based on the location of the erosion it is possible that it is the previously implanted flat mesh that was eroded.A manufacturing review was performed and found no evidence of a manufacturing related cause for the alleged event.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.Not returned to manufacturer.

Event Description

The following is based on a review of medical records provided to davol by the patient's attorney: on (b)(6) 2007 - the patient was diagnosed with a cystocele, rectocele, stress urinary incontinence and vaginal vault prolapse.The patient underwent an anterior/posterior colporrhaphy with implant of a non davol mesh, implant of a non-davol transobturator mesh sling and a perineorrhaphy.On (b)(6) 2008 - the patient was diagnosed with a complete vaginal vault prolapse.The patient underwent an abdominal sacrocolpopexy with implant of a davol flat mesh.On (b)(6) 2014 - patient had an md office visit and was noted to have erosion of implanted vaginal mesh to surrounding tissue noted to be a 2 cm area of mesh on the right side of the vaginal cuff.A purulent vaginal discharge was also observed on exam.Possible rectovaginal fistula based on patient's described symptoms, however, not seen or palpated on exam.

• 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: steven figueroa ; 100 crossings blvd.; warwick, RI 02886 ; 4018258460
• MDR Report Key: 6326624
• MDR Text Key: 67273112
• Report Number: 1213643-2017-00106
• 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: Attorney
• Type of Report: Initial
• Report Date: 02/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2010
• Device Catalogue Number: 0112680
• Device Lot Number: 43BPD021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2005
• 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 Weight: 65