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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. BARD FLAT MESH SURGICAL MESH Back to Search Results
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.

 
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Brand NameBARD FLAT MESH
Type of DeviceSURGICAL 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 Key6078431
MDR Text Key59132922
Report Number1213643-2016-00505
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPREAMENDMENT
Number of Events Reported1
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 Received11/04/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2009
Device Catalogue Number0112720
Device LOT Number43DOD055
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received11/21/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/30/2004
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: 11/04/2016 Patient Sequence Number: 1
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