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

Catalog Number 0112720

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

Patient Problems Urinary Tract Infection (2120); Hematuria (2558)

Event Date 03/26/2013

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown whether the device may have caused or contributed to the reported event.The medical records provided show the patient experienced recurrent urinary tract infections, 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 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) 2004 - the patient was diagnosed with stress urinary incontinence (sui) and underwent a laparoscopic burch procedure with implant of a davol flat mesh.On (b)(6) 2013 - patient was diagnosed with bladder calcification, recurrent urinary tract infection, hematuria and bladder foreign body.The patient underwent a laser destruction of bladder calculus and removal of foreign body from bladder, i.E staples.Per the operative report the mesh was then seen and was acting as a nidus for this and in between the mesh there were 2 metallic staples.Utilizing the laser, the entire calcified stone was fragmented and then as much of the mesh as possible was fragmented, "kind of melted away from the staples." the staples were then hit right at the base so they became fragile and were grabbed with a grasper.There staples were then pulled out of the bladder wall.Once the staples were removed the laser was used to fulgurate and destroy the mesh further in the bed.

• 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: 6322372
• MDR Text Key: 67142101
• Report Number: 1213643-2017-00091
• 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: 02/10/2017

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: 08/31/2008
• Device Catalogue Number: 0112720
• Device Lot Number: 43HND077
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/18/2017
• Initial Date FDA Received: 02/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2003
• 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: 67 YR