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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 0112720
Device Problems Defective Device (2588); Insufficient Information (3190)
Patient Problems Erosion (1750); Incontinence (1928); Pain (1994)
Event Date 02/12/2015
Event Type  Injury  
Manufacturer Narrative

A manufacturing review was performed and found no evidence of a manufacturing related cause for the reported event. With the current information available, there is no way to determine whether the davol flat mesh may have caused or contributed to the problems experienced due to limited clinical information provided. 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) 2008- the patient was previously diagnosed with pelvic organ prolapse (uterine, cystocele, rectocele) and urinary tract incontinence. The patient underwent a two part procedure which included a laparotomy, total abdominal hysterectomy, bilateral salpingo-oophorectomy, sacrcolpopexy with implant of a davol flat mesh and a marshall-marchetti-krantz procedure. On (b)(6) 2015 - the patient was diagnosed with a vaginal vault prolapse, anterior vaginal wall prolapse, pelvic vaginal pain, right lower quadrant pain, "mechanical complication of the mesh implant," rectocele, urinary incontinence and underwent a robotic-assisted laparoscopic partial removal of the bard flat mesh, laparoscopic assisted uterosacral ligament suspension, combined anterior and posterior repair followed by cystourethoscopy. Per the op report details "a significantly thinned out vaginal lining was noted. Palpable folded mesh (davol flat) was noted and extended from the vaginal apex to mid vagina with a suspected early erosion of the mesh (davol flat) at the vaginal cuff. Laparoscopic examination of the abd and pelvis revealed minimal adhesions. ".

 
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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 Key6206639
MDR Text Key63357907
Report Number1213643-2016-00591
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 12/27/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/27/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/07/2010
Device Catalogue Number0112720
Device LOT Number43GPD071
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 Manufactured07/11/2005
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: 12/27/2016 Patient Sequence Number: 1
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