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

Catalog Number UNKAA030

Device Problems Defective Device (2588); Extrusion (2934); Insufficient Information (3190)

Patient Problems Erosion (1750); Unspecified Infection (1930); Pain (1994)

Event Date 08/14/2015

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 infection, erosion, pain and extrusion. Extrusion is listed as a known possible 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. ¿ without a lot number a review of the manufacturing records could not be conducted. Based on the description of the location of the exposed/extruded/eroded mesh this appears to be the bard flat mesh, however there was a non-bard davol mesh placed in the same proximity. With the current information 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) 2012 - the patient underwent a sacrocolpopexy by laparotomy, non bard davol tension free vaginal tape urethropexy, anterior/posterior colporrhaphy and surgisis (non bad davol) augmented posterior repair due to diagnosis of stage ii vaginal vault prolapse, pelvic organ prolapse, cystorectocele with sui and weakness of the rectovaginal fascia. Operative dictation notes a "bard mesh" was implanted at this time and was "fitted between the vaginal vault and the sacrum. " on (b)(6) 2014 - (b)(6) 2015 - the patient had multiple md office visits for complaints of pelvic pain, dyspareunia, discharge, mesh exposure and bleeding after intercourse since the 2012 surgery. Md notes indicate there was mesh erosion of a 1cm area of mesh on the right side of vaginal apex with a small amount of purulent discharge "from mesh" in which she was treated for mesh infection. On (b)(6) 2015 - the patient underwent additional surgery to remove flat mesh in which the operative findings noted the patient was "found to have a very obvious visible and palpable area of eroded vaginal mesh of the anterior aspect of the vaginal wall in its most proximal extent just distal to the vaginal cuff. There was no other palpable or visible mesh erosion elsewhere on the anterior wall nor was there any sign of any erosion or foreign body on the posterior vaginal wall. " upon removal of the flat mesh it was also noted "the area of mesh extrusion was infected with a somewhat purulent discharge and a foul odor encountered on exposing the area.

• 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: 6139432
• MDR Text Key: 61291409
• Report Number: 1213643-2016-00546
• 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: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNKAA030
• 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: 11/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 12/01/2016 Patient Sequence Number: 1