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

Catalog Number 0112640

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

Patient Problems Erosion (1750); Prolapse (2475)

Event Date 11/04/2013

Event Type  Injury  

Manufacturer Narrative

Based on the information provided we are unable to determine to what extent if any, the bard device may have caused or contributed to the patient's post implant experience.A review of the manufacturing records was performed and found that the lot was manufactured to specification.If additional information is obtained, a supplemental mdr will be submitted.Not returned.

Event Description

The following is based on medical records provided by the patient's attorney: on (b)(6) 2008 - the patient was diagnosed with cystocele and underwent a cystocele repair with implant of a bard/davol flat mesh.Per the implant op report, "the bladder was dissected free from the anterior vaginal wall.The distal and proximal lateral condensations were then secured using vicryl sutures.Bard polypropylene mesh was then fashioned and tied using these anchoring sutures.There was excellent reduction of the cystocele at the end of the procedure." on (b)(6) 2013 - the patient was diagnosed with a recurrent cystocele, rectocele, enterocele, erosion of mesh (davol flat), vulvar lesion, stress urinary incontinence (sui) and underwent a uterosacral vaginal vault suspension, excision of the bard/davol flat mesh from the anterior compartment in its entirety, cystocele repair, rectocele repair, enterocele repair, urethrocele repair, perineorrhaphy, implant of a non bard/davol tvt exact sling, vulvar biopsy and cystoscopy.Per the operative report details, "she had evidence of a small area of erosion at the apex of the vagina.The anterior vaginal wall was approximately 0.5 cm that was exposed.She also had significant granulation along the epithelium, suggesting very close proximity of the mesh (davol flat) to the epithelium.A midline incision was made from the other mid urethral incision down through the apex of the vagina and along the posterior vaginal wall.The mesh (davol flat) was embedded and very adherent to the epithelium very close to the epithelium along the left half of the anterior vaginal wall.Significant care was taken to carefully tease away the mesh (davol flat) from the epithelium to allow for healing.Once this was removed, the portion of the mesh (davol flat) that was embedded in the pubocervical fascia were carefully dissected away.Entire portion of mesh (davol flat) in the anterior compartment was removed.The cystocele was elevated with suture".

• 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: laura berg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 6212814
• MDR Text Key: 63520185
• Report Number: 1213643-2016-00593
• 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: 12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2011
• Device Catalogue Number: 0112640
• Device Lot Number: 43KQD237
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2006
• 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: 68 YR