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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 0112680
Device Problems Defective Device (2588); Insufficient Information (3190)
Patient Problems Erosion (1750); Fistula (1862); Abnormal Vaginal Discharge (2123)
Event Type  Injury  
Manufacturer Narrative

Currently, it is unknown whether the device may have caused or contributed to the reported event. Based on a review of medical records, the patient experienced discharge, erosion and fistula formation. Fistula formation is listed as a known possible adverse reaction in the instructions-for-use. It was further reported that there was erosion of implanted vaginal mesh. There is no information that would identify the exact mesh that was eroded, as the patient has a history of multiple implants; however, it appears, based on the location of the erosion it is possible that it is the previously implanted flat mesh that was eroded. A manufacturing review was performed and found no evidence of a manufacturing related cause for the alleged event. 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) 2007 - the patient was diagnosed with a cystocele, rectocele, stress urinary incontinence and vaginal vault prolapse. The patient underwent an anterior/posterior colporrhaphy with implant of a non davol mesh, implant of a non-davol transobturator mesh sling and a perineorrhaphy. On (b)(6) 2008 - the patient was diagnosed with a complete vaginal vault prolapse. The patient underwent an abdominal sacrocolpopexy with implant of a davol flat mesh. On (b)(6) 2014 - patient had an md office visit and was noted to have erosion of implanted vaginal mesh to surrounding tissue noted to be a 2 cm area of mesh on the right side of the vaginal cuff. A purulent vaginal discharge was also observed on exam. Possible rectovaginal fistula based on patient's described symptoms, however, not seen or palpated on exam.

 
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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 Key6326624
MDR Text Key67273112
Report Number1213643-2017-00106
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 CONSUMER,OTHER
Reporter Occupation ATTORNEY
Type of Report Initial
Report Date 02/13/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/13/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2010
Device Catalogue Number0112680
Device LOT Number43BPD021
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/18/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/15/2005
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: 02/13/2017 Patient Sequence Number: 1
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