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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 0112660
Device Problem Defective Device (2588)
Patient Problems Erosion (1750); Pain (1994); Abnormal Vaginal Discharge (2123)
Event Date 01/13/2015
Event Type  Injury  
Manufacturer Narrative

Currently, it is unknown whether the device may have caused or contributed to the reported event. 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: (b)(6) 2012 - patient was diagnosed with pelvic organ prolapse, stress urinary incontinence and rectocele. The patient underwent implant of a bard/davol flat mesh and a non-bard/davol midurethral sling. (b)(6) 2014 - the patient had an office exam. Patient complained of vaginal discharge and pain. Patient was noted to have granulation tissue vs prolapsed fallopian tube as well as visible suture at apex of vagina. An attempt was made to remove exposed vaginal mesh in office, however this was unsuccessful due to poor visualization and patient discomfort, therefore a plan was made for vaginal cuff revision in the o. R. , however initial surgery plan cancelled due to graves disease and poorly controlled hyperthyroidism. (b)(6) 2015 - patient underwent a vaginal cuff revision with partial removal of the bard/davol flat mesh, non-bard/davol suture material as well cystoscopy due to mesh and suture erosion. The op report details described the patient having "very thin epithelium" with the mesh directly below it.

 
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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 Key5475417
MDR Text Key39519493
Report Number1213643-2016-00081
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 02/08/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/02/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2017
Device Catalogue Number0112660
Device LOT NumberHUWD0433
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received02/08/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/20/2012
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: 03/02/2016 Patient Sequence Number: 1
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