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

Catalog Number 0112720

Device Problems Defective Device (2588); Material Deformation (2976); Insufficient Information (3190)

Patient Problems Erosion (1750); Pain (1994); Abnormal Vaginal Discharge (2123)

Event Date 03/22/2011

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event.Based on the information received the patient underwent multiple vaginal surgeries and therefore, it is unclear if either of the davol flat mesh caused or contributed to the findings post implants.It appears the vaginal tissue may have become very thin due to the multiple surgical procedures and may have been unable to support the areas of mesh placement; therefore leading to seom erosion.There is no indication in the medical records that either of the flat mesh were completely explanted.This file represents the davol flat mesh implanted on (b)(6) 2005.Another file has been created for the flat mesh implanted on (b)(6) 2003.With the current information available no conclusion can be made at this time.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) 2003 - the patient was diagnosed with cystorectocele and stress urinary incontinence.The patient underwent implant of a davol flat mesh (#1), anterior posterior colporrhaphy, bilateral paravaginal defect repair, and sling cystoscopy.On (b)(6) 2005 - the patient underwent a total abdominal hysterectomy, abdominal sacrocolpopexy, & enterocele repair with implant of a second davol flat mesh (#2).No operative detail has been provided, however, it appears this (#2) flat mesh was placed posteriorly.On (b)(6) 2010--(b)(6) 2011-- patient evaluated by md for complaints of dyspareunia, vaginal odor, rectocele and mixed incontinence.Patient diagnosed with apical mesh erosion (#2).On (b)(6) 2011-- the patient was diagnosed with vaginal outlet relaxation, vaginal apical mesh erosion, and site specified posterior defect.The patient underwent apical vaginal mesh excision (#2), repair of vaginal apex, site specified posterior repair, perineorrhaphy and cystoscopy.On (b)(6) 2011 - the patient was evaluated each month be her md with complaints of tenderness of the vagina and pelvic floor as well as some palpation and eventual recurrence of mesh erosion.On (b)(6) 2013 - the patient had an md follow up visit.It was noted the patient had erythema, palpable mesh noted as very painful.No apical erosion, however there was urinary incontinence.Patient was treated for uti and vaginitis and planned for surgical repair.On (b)(6) 2013 - the patient underwent exam under anesthesia with excision of right anterior vaginal mesh (#1) contracture and cystourethroscopy.Based on the description of the mesh location noting the mesh to be anterior and near the bladder neck, this appears to be mesh the first flat mesh implanted.On (b)(6) 2013 - (b)(6) 2014 - the patient had multiple md office visits with identification of "foreign object" in vagina.Suture removed with note of a small mesh (#1) exposure and bunching noted of the second flat mesh (#2) at the apex of the vagina.On (b)(6) 2014 - the patient underwent an exam under anesthesia with excision of right anterior vaginal mesh (#1) erosion.Patient underwent an exam under anesthesia, excision of right anterior vaginal sulcus mesh (#1) erosion, and cystoscopy.

Manufacturer Narrative

This supplemental is being sent to provide the 510k information not previously provided.Updated: date received by mfr, pma#, type of reports, if follow-up, what type?, additional mfr narrative.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) 2003 - the patient was diagnosed with cystorectocele and stress urinary incontinence.The patient underwent implant of a davol flat mesh (#1), anterior posterior colporrhaphy, bilateral paravaginal defect repair, and sling cystoscopy.On (b)(6) 2005 - the patient underwent a total abdominal hysterectomy, abdominal sacrocolpopexy, & enterocele repair with implant of a second davol flat mesh (#2).No operative detail has been provided, however, it appears this (#2) flat mesh was placed posteriorly.On (b)(6) 2010-- (b)(6) 2011-- patient evaluated by md for complaints of dyspareunia, vaginal odor, rectocele and mixed incontinence.Patient diagnosed with apical mesh erosion (#2).On (b)(6) 2011-- the patient was diagnosed with vaginal outlet relaxation, vaginal apical mesh erosion, and site specified posterior defect.The patient underwent apical vaginal mesh excision (#2), repair of vaginal apex, site specified posterior repair, perineorrhaphy and cystoscopy.Om (b)(6) 2011 - the patient was evaluated each month be her md with complaints of tenderness of the vagina and pelvic floor as well as some palpation and eventual recurrence of mesh erosion.On (b)(6) 2013 - the patient had an md follow up visit.It was noted the patient had erythema, palpable mesh noted as very painful.No apical erosion, however there was urinary incontinence.Patient was treated for uti and vaginitis and planned for surgical repair.On (b)(6) 2013 - the patient underwent exam under anesthesia with excision of right anterior vaginal mesh (#1) contracture and cystourethroscopy.Based on the description of the mesh location noting the mesh to be anterior and near the bladder neck, this appears to be mesh the first flat mesh implanted.On (b)(6) 2013 - (b)(6) 2014 - the patient had multiple md office visits with identification of "foreign object" in vagina.Suture removed with note of a small mesh (#1) exposure and bunching noted of the second flat mesh (#2) at the apex of the vagina.On (b)(6) 2014 - the patient underwent an exam under anesthesia with excision of right anterior vaginal mesh (#1) erosion.Patient underwent an exam under anesthesia, excision of right anterior vaginal sulcus mesh (#1) erosion, and cystoscopy.

• 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: 6078431
• MDR Text Key: 59132922
• Report Number: 1213643-2016-00505
• 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: other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 10/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2009
• Device Catalogue Number: 0112720
• Device Lot Number: 43DOD055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 11/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2004
• 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: 52 YR
• Patient Weight: 89