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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. BARD SOFT MESH SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. BARD SOFT MESH SURGICAL MESH Back to Search Results
Catalog Number 0117009
Device Problems Defective Device (2588); Extrusion (2934); Insufficient Information (3190)
Patient Problems Erosion (1750); Unspecified Infection (1930); Pain (1994); No Information (3190)
Event Date 03/08/2017
Event Type  Injury  
Manufacturer Narrative
This is an addendum to the initial mdr to document additional information and medical records provided by the patients attorney. Currently, it is unknown to what extent the device may have caused or contributed to the reported event. The information provided alleges that the patient reported post implant complication on (b)(6) 2016 of "vaginal yeast infection" though there is no indication in the provided medical records that the vaginal yeast infection was related to the mesh, and (b)(6) 2017 complaints of a ¿pinch¿ she feels in the left vaginal area when exercising which the doctor thinks may be pressure related to increased physical activity or weight on the periosteum from the bladder sling. Based on the information received, there is no way to determine whether the bard/davol mesh may have caused or contributed to the problems experienced due to the patient's medical/surgical history and the limited clinical information received. Should additional information be provided a supplemental emdr will be submitted.
 
Event Description
As reported on 12/06/2016, the following is based on information provided by the patient's attorney: (b)(6) 2011- the patient was diagnosed with a stress urinary incontinence (sui), urethral hypermobility and underwent a bladder suspension with a transvaginal tape implant using a bard/davol soft mesh. The patient's attorney alleges unspecified adverse patient outcomes associated with use of device. Addendum based on additional information provided by patients attorney which included the medical operative report and general patient outcome allegations: (b)(6) 2016: the patient had md office exam with complaints of chronic pelvic pain. Per exam notes, patient was noted to have external genitalia inflammation. Patient was diagnosed with a vaginal yeast infection and prescribed oral antifungal medications and an external cream. (b)(6) 2017: the patient had an md office exam with complaints of a ¿pinch¿ she feels in the left vaginal area when exercising. She reported it is not severe pain but worries it might be a problem with the mesh (davol soft). Patient reported not having any bladder symptoms and control was good. She denied dyspareunia; however, the patient gained a considerable amount of weight. The exam noted no abnormalities and the physician suspected ¿she is having some pressure, related to increased physical activity or weight on the periosteum from the bladder sling (davol soft). ¿ the patient didn¿t feel it was enough to warrant intervention and was advised to change her dietary habits for weight loss and ibuprofen to ¿settle any irritation. ¿ alleged outcomes attributed to device of pain, erosion, extrusion, infection, urinary problems and multiple kidney infections over past 2 years.
 
Manufacturer Narrative
Based on the information available at this time, no conclusions can be made. The patient's attorney alleges unspecified adverse patient outcomes associated with use of device and the medical records were limited to the implant tracking log only. 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. 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.
 
Event Description
The following is based on information provided by the patient's attorney: on (b)(6) 2011- the patient was diagnosed with a stress urinary incontinence (sui), urethral hypermobility and underwent a bladder suspension with a transvaginal tape implant using a bard/davol soft mesh. The patient's attorney alleges unspecified adverse patient outcomes associated with use of device.
 
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Brand NameBARD SOFT 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
francesca santamaria
100 crossings blvd.
warwick, RI 02886
4018258538
MDR Report Key6155872
MDR Text Key255657795
Report Number1213643-2016-00562
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K052155
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Attorney
Type of Report Initial,Followup
Report Date 03/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2016
Device Catalogue Number0117009
Device Lot NumberHUVD1279
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received03/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/18/2011
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: 12/08/2016 Patient Sequence Number: 1
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