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 Adhesion(s) (1695); Fistula (1862); Prolapse (2475)

Event Date 10/20/2010

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event.Based on the current medical records provided, there is no way to determine whether the davol mesh may have caused or contributed to the problems experienced due to the patient's medical history, the additional surgical procedures with implant of non-bard davol mesh products and the patient's previously noted "thin vaginal tissues" prior to implant of the davol mesh.The medical records indicate the patient experienced adhesions and fistula.Both adhesions and fistula are listed as known possible adverse reaction in the instructions-for-use.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.Device 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 vaginal vault prolapse, voiding dysfunction and occult urinary incontinence.The patient underwent cystoscopy, abdominal sacrocolpopexy with implant of davol flat mesh, implant of a non-bard davol midureteral sling and an enterocele repair.On (b)(6) 2007 - the patient was diagnosed with occult genuine stress incontinence and instrinsic sphincter deficiency, non-bard davol mesh extrusion and granulation tissue.The patient underwent a revision procedure of the non-bard davol sling.On (b)(6) 2010 - patient had an md office visit with complaints of occasional incontinence and per the md office exam notes "the midureteral sling has extruded again." on (b)(6) 2010 - patient had an in office procedure which included removal of the non-bard davol midureteral sling and injection of a non-bard davol bulking agent.On (b)(6) 2010 - the patient was diagnosed with instrinsic sphincter deficiency with persistent stress urinary incontinence and non-bard davol vaginal mesh extrusion.The patient underwent implant of a non-bard/davol retropubic midureteral sling followed by cystoscopy, vaginal mesh (non-bard davol) excision and reclosure of vaginal apex.On (b)(6) 2010 - the patient was diagnosed with an enterovaginal fistula and underwent exploratory laparotomy, takedown of enterovaginal fistula, takedown of adhesions and a partial explant of the davol flat mesh.On (b)(6) 2010 - the patient had an md office exam with indication that "the cuff was intact.No granulation tissue was present.Anterior wall and cuff supported." on (b)(6) 2011 - the patient had an md office visit with indication that the patient had "a recurrent posterior vaginal wall prolapse with a fairly well supported anterior wall pex and the rectovaginal exam is within normal limits.".

• 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: 6152290
• MDR Text Key: 61699967
• Report Number: 1213643-2016-00560
• 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: 12/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2011
• Device Catalogue Number: 0112660
• Device Lot Number: 43DQD052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 11/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2006
• 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: 70 YR