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

Catalog Number 0112680

Device Problems Defective Device (2588); Extrusion (2934)

Patient Problems Unspecified Infection (1930); Pain (1994); Prolapse (2475)

Event Date 06/28/2013

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown whether the device may have caused or contributed to the reported event, however medical records indicate only the non-bard/davol midurethral sling which was implanted in 2006 was explanted.The bard/flat mesh was never removed.Based on the patient's legal fact sheet, it is alleged the patient experienced pain, extrusion and infection.The medical records provided do not mention extrusion of mesh or any type of infection suffered by the patient, however, extrusion is listed as a known adverse reaction in the instructions-for-use.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.With the current information available no conclusion can be made.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: (b)(6) 2002 - patient had a symptomatic pelvic prolapse which resulted in stress urinary incontinence.Patient underwent a total abdominal hysterectomy with bilateral salpingo-oophorectomy, abdominal sacral colpopexy with bard/davol flat mesh, paravaginal defect repair, birch retropubic urethropexy, rectocele repair, cystoscopy, and suprapubic catheter placement.(b)(6) 2006 - patient continued to have stress urinary incontinence and underwent implant of a non-bard/davol midurethral sling.No mention of the previously placed davol flat mesh in the operative details for this procedure.(b)(6) 2013 - patient presented with vaginal perforation of the synthetic mesh (non-bard/davol) and discomfort related to the 2006 mesh implant.The patient underwent explant of the midurethral sling mesh.Operative details note the mesh (bard/davol flat) in relation to the endopelvic fascia and anterior abdominal wall was not removed, only the non-bard/davol mesh in relation to the urethra and the anterior vaginal wall was completely excised.The patient's legal fact sheet alleges the patient experienced extrusion, infection, pain , and additional surgical invasive procedure.

• 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: 5483598
• MDR Text Key: 39780455
• Report Number: 1213643-2016-00091
• 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: 02/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2006
• Device Catalogue Number: 0112680
• Device Lot Number: 43LLD021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 02/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2001
• 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: 66 YR