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); Pain (1994); Urinary Tract Infection (2120); Disability (2371)

Event Date 05/20/2015

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event. The medical records indicate the patient experienced recurrent urinary tract infections, pain and erosion. In regards to infection, the warning section of the instructions-for-use states "if an infection develops, treat the infection aggressively. The prosthesis may not have to be removed. An unresolved infection, however, may require removal of the prosthesis. ¿ a manufacturing review was performed and found no evidence of a manufacturing related cause for the reported event. With the current information available, there is no way to determine whether the davol mesh may have caused or contributed tot he problems experienced due to the patient's medical/surgical history and the non-bard davol suture material that was implanted with flat mesh. If additional event and/or evaluation information is obtained, a follow up mdr will be submitted. 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 symptomatic cystocele, rectocele, genuine stress urinary incontinence and underwent a laparoscopic exfulguration of fallopian tubes bilateral, modified anterior/posterior colporrhaphy, modified pereya with davol flat mesh, suprapubic catheter placement and cystoscopy. On (b)(6) 2014 - patient had previously been diagnosed with vaginal pain, dyspareunia as well as retention of urine and recurrent urinary tract infections. Patient was seen for hydronephrosis and underwent transvesical placement of double-j stents. The patient continued to have infections and right lumbar pain. It was found that the stent was not in good position and was repositioned at least 2 times. The stent was found in the ureteropelvic junction. The operative details were not provided for these procedures. On (b)(6) 2015 - the patient presented to the er with right lower abdominal pain radiating to leg, flank discomfort. The patient has a history of ureteral obstruction and stent placement and replacement. The patient was diagnosed with retropubic mesh (davol flat) erosion. On (b)(6) 2015 - the patient was diagnosed with right ureteral obstruction and erosion of mesh into the bladder. The patient underwent a urethrolysis, removal of flat mesh, removal of retropubic non-bard davol sutures, vaginal reconstruction and cystoscopy. It appears all davol mesh was removed at this time. On (b)(6) 2015 - the patient underwent abdominal exploration, lysis of adhesions, exploration of the right ureter with severe hydroureter all the way to the bladder, exploration and dissection of the left ureter, bilateral ureteric reimplantation, placement of a suprapubic catheter and bilateral ureteric stents. There was no indication or visualization of any residual davol mesh noted in the operative details provided.

• 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: 6193193
• MDR Text Key: 62959473
• Report Number: 1213643-2016-00582
• 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,Followup
• Report Date: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 01/31/2011
• Device Catalogue Number: 0112640
• Device Lot Number: 43AQD003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: Hospital
• Date Manufacturer Received: 10/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/21/2016 Patient Sequence Number: 1