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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
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. ".
 
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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 Key6885828
MDR Text Key87217491
Report Number1213643-2017-00610
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PREAMENDMENT
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 09/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/28/2009
Device Model Number0112660
Device Catalogue Number0112660
Device Lot Number43FOD013
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 Received08/28/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/11/2004
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: 09/22/2017 Patient Sequence Number: 1
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