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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); Prolapse (2475)
Event Date 11/04/2013
Event Type  Injury  
Manufacturer Narrative

Based on the information provided we are unable to determine to what extent if any, the bard device may have caused or contributed to the patient's post implant experience. A review of the manufacturing records was performed and found that the lot was manufactured to specification. If additional information is obtained, a supplemental mdr will be submitted. Not returned.

 
Event Description

The following is based on medical records provided by the patient's attorney: on (b)(6) 2008 - the patient was diagnosed with cystocele and underwent a cystocele repair with implant of a bard/davol flat mesh. Per the implant op report, "the bladder was dissected free from the anterior vaginal wall. The distal and proximal lateral condensations were then secured using vicryl sutures. Bard polypropylene mesh was then fashioned and tied using these anchoring sutures. There was excellent reduction of the cystocele at the end of the procedure. " on (b)(6) 2013 - the patient was diagnosed with a recurrent cystocele, rectocele, enterocele, erosion of mesh (davol flat), vulvar lesion, stress urinary incontinence (sui) and underwent a uterosacral vaginal vault suspension, excision of the bard/davol flat mesh from the anterior compartment in its entirety, cystocele repair, rectocele repair, enterocele repair, urethrocele repair, perineorrhaphy, implant of a non bard/davol tvt exact sling, vulvar biopsy and cystoscopy. Per the operative report details, "she had evidence of a small area of erosion at the apex of the vagina. The anterior vaginal wall was approximately 0. 5 cm that was exposed. She also had significant granulation along the epithelium, suggesting very close proximity of the mesh (davol flat) to the epithelium. A midline incision was made from the other mid urethral incision down through the apex of the vagina and along the posterior vaginal wall. The mesh (davol flat) was embedded and very adherent to the epithelium very close to the epithelium along the left half of the anterior vaginal wall. Significant care was taken to carefully tease away the mesh (davol flat) from the epithelium to allow for healing. Once this was removed, the portion of the mesh (davol flat) that was embedded in the pubocervical fascia were carefully dissected away. Entire portion of mesh (davol flat) in the anterior compartment was removed. The cystocele was elevated with suture".

 
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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
laura berg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key6212814
MDR Text Key63520185
Report Number1213643-2016-00593
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 12/05/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/29/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2011
Device Catalogue Number0112640
Device LOT Number43KQD237
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 Received12/05/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/06/2006
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: 12/29/2016 Patient Sequence Number: 1
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