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

Model Number 0112660

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

Patient Problems Erosion (1750); Pain (1994); Prolapse (2475)

Event Date 02/21/2006

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 provided indicated the patient experienced pain, erosion and prolapse.A manufacturing review was performed which found no anomalies during the manufacturing process of the device.With the current information available, no definitive 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: on (b)(6) 2004 - the patient was diagnosed with cystocele, enterocele, rectocele and moderate sigmoid pelvic adhesions.The patient underwent an abdominal sacrocolpopexy with implant of a bard flat mesh and two non-bard davol "titanium screws with polypropylene sutures.On (b)(6) 2005 - the patient was diagnosed with extrusion of vaginal mesh at the vaginal apex.The patient was thought to previously have some mild vaginal mesh erosion at the apex of her vagina and used vaginal estrogen over three months with mild improvement in symptoms, but continued to have vaginal pain and the sensation of something at the very top of her vagina that was painful with intercourse.The patient opted for surgical excision, with a vaginal approach.The patient underwent a partial explant of the bard flat mesh along with 2 polypropylene sutures.Per op details "inspection revealed the extruded mesh at the very apex of the vagina.This was grasped with an allis, pulled down, and excised with scissors.The area was carefully inspected and 2 of the polypropylene sutures that were noted to be in the area were also excised." on (b)(6) 2006 - the patient was diagnosed with vaginal mesh extrusion, suture extrusion and mild cystocele.The patient underwent a partial explant of the bard flat mesh, removal of the non-bard davol sutures and implant of a non-bard davol mid-urethral sling.Per the op report details "what was seen extruding was on blue prolene suture which was grasped, cut and removed in its entirety.Another prolene suture was encountered and removed as well as some of the mesh in 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: 6885828
• MDR Text Key: 87217491
• Report Number: 1213643-2017-00610
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016516
• UDI-Public: (01)00801741016516(17)090628(10)43FOD013
• 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: 09/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2009
• Device Model Number: 0112660
• Device Catalogue Number: 0112660
• Device Lot Number: 43FOD013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2004
• 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: 53 YR