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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 0112640
Device Problems Defective Device (2588); Extrusion (2934)
Patient Problems Erosion (1750); Pain (1994); Prolapse (2475)
Event Type  Injury  
Manufacturer Narrative
Currently, it is unknown to what extent if any the device may have caused or contributed to the reported event. It is alleged the patient experienced extrusion, erosion, prolapse and pain. The medical records provided do not support the allegation of any type of mesh erosion or extrusion experienced by the patient. While the medical records do not support the allegation of mesh extrusion, extrusion is listed as a known possible adverse reaction in the instructions-for-use. With the current information available, there is no way to determine to what extent the bard devices may have caused or contributed to the problems experienced post implant. No definitive conclusion can be made at this time, if additional event and/or evaluation information is obtained, a follow up mdr will be submitted. A second file with an additional mdr has already been submitted for the second flat mesh implanted in 2008. 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 and the patient's legal claim provided to davol by the patient's attorney: on (b)(6) 2008 - the patient was diagnosed with urinary stress incontinence and underwent a laparoscopic burch cystourethroscopy with implant of two bard flat mesh devices. Per the operative details "the strips of polypropylene mesh were then put in place and secured bilat to the paraurethral and paravaginal tissues with the protack staples. The mesh was then placed on moderate tension and coopers ligament was secured with the protack staples. " on (b)(6) 2012 - the patient was diagnosed with stress incontinence with cystocele and underwent a primary bladder suspension using a non-bard davol prolene suture. The operative details provided did not mention any visualization or involvement of the bard mesh devices. On (b)(6) 2013 - this is a patient who had three previous operations by three different surgeons, last one done about ten months ago. The patient was continent for a while and then had a severe coughing and the patient started leaking again. The patient was diagnosed with a recurrent cystocele and grade ii-iii stress incontinence. The patient underwent a redo of bladder neck suspension. The operative details provided did not mention any visualization or involvement of the bard mesh devices. The patient's legal claim alleges the patient experienced erosion, extrusion, pain, urinary problems, bowel problems and prolapse.
 
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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 Key6633665
MDR Text Key77325931
Report Number1213643-2017-00345
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 06/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/28/2012
Device Catalogue Number0112640
Device Lot NumberHURB4840
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 Received05/15/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/15/2007
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: 06/12/2017 Patient Sequence Number: 1
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