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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); Insufficient Information (3190)
Patient Problems Erosion (1750); Inflammation (1932); Abnormal Vaginal Discharge (2123)
Event Date 03/01/2007
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 indicate ¿the bioarc was fashioned with a 2 x 4 segment of prolene mesh and this was attached to the bioarc arms and brought up underneath the urethra. ¿ based on the information provided, it is unclear and cannot be determined if/where all three mesh slings were placed during this procedure. The medical records indicate the patient experienced pain, inflammation, erosion, bleeding and vaginal discharge. Of note the procedure performed in (b)(6) of 2007 appears to be the onset of the patient's symptoms caused by mesh. A manufacturing review was performed which found no anomalies during the manufacturing process of the device. Based on the medical records provided, as well as the patient having had multiple mesh implanted, it is unclear which mesh 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. 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. Device 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) 2005 - the patient was diagnosed with urinary stress incontinence and underwent implant of a non-bard davol urethral sling. On (b)(6) 2006 - the patient was diagnosed with recurrent stress urinary incontinence and urethral hypermobility. The patient underwent a suburethral sling procedure using a non bard davol "bioarc" sling kit, a non bard davol "sparc" sling kit and a bard 1 x 4 inch flat mesh. Per the implant operative details "the bioarc was fashioned with a 2 x 4 segment of prolene mesh and this was attached to the bioarc arms and brought up underneath the urethra. " on (b)(6) 2007 - the patient was diagnosed with stress urinary incontinence and exposed vaginal mesh. The patient underwent a revision procedure which included trimming the edges of the vaginal (unspecified) mesh. On (b)(6) 2012 - the patient began to notice some vaginal bleeding and on exam in the office, the patient appeared to have an area of irritation from the suture or from the sling itself. Per operative details "there was found to be an area of granulation tissue that significantly friable and bleeding. This area was dissected out, and at the base that it was noted to be a suture and (unspecified) mesh materials appeared to be the origin. That was removed. The suture and mesh in that area were removed. " on (b)(6) 2015 - the patient was diagnosed with (unspecified) anterior vaginal wall mesh exposure, granulation tissue and urinary incontinence. The patient underwent unspecified mesh excision with revision of tvt, cystoscopy, anterior vaginal wall repair and augmentation with implant of a non bard davol porcine graft. On (b)(6) 2015 - the patient had md office pelvic exams due to complaints of pelvic pain, vaginal discharge, vaginal bleeding. The surgeon noted on exam ¿granulation tissue and exposure of (unspecified) implanted vaginal mesh and other prosthetic materials into the vagina. ¿ on (b)(6) 2015 - the patient was diagnosed with (unspecified) mesh exposure granulation tissue under the right suburethral space and fornix, stress urinary incontinence and vaginal bleeding the patient underwent excision of granulation tissue and (unspecified) mesh retropubically and transobturator on the right side and revision. On (b)(6) 2015 - the patient was diagnosed with intrinsic sphincter deficiency with stress urinary incontinence and underwent a procedure which included injection of a urethral bulking agent followed by cystoscopy. Per the findings no mesh in bladder, urethra or vagina.

 
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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 Key6551361
MDR Text Key74630758
Report Number1213643-2017-00289
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 05/08/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/08/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/28/2010
Device Catalogue Number0112640
Device LOT Number43LPD001
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 Received04/10/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/02/2005
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: 05/08/2017 Patient Sequence Number: 1
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