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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 0112650
Device Problem Defective Device (2588)
Patient Problem Injury (2348)
Event Type  Injury  
Manufacturer Narrative
Currently, it is unknown whether the device may have caused or contributed to the reported event. The patient's attorney did not allege a specific device failure or patient injury. A manufacturing review was performed and found no evidence of a manufacturing related cause for the alleged event. 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 and the attorney's response letter provided to davol by the patient's attorney: on (b)(6) 2004 - the patient was diagnosed with dysfunctional bleeding, menorrhagia, pelvic relaxation and stress incontinence. The patient underwent a multi-part procedure with implant of a non-bard davol sling. On (b)(6) 2011 - patient was diagnosed with uterovaginal prolapse, stress incontinence and excess bmi. The patient underwent a total abdominal hysterectomy, bilateral salpingo-oophorectomy, vaginal abdominal colpopexy with implant of a davol flat mesh, birch cystourethropexy, cystoscopy and enterocele repair. The attorney alleges the patient experienced injury and additional invasive surgical procedure.
 
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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 Key6190546
MDR Text Key62871217
Report Number1213643-2016-00580
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 12/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/30/2016
Device Catalogue Number0112650
Device Lot NumberHUVE1183
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received11/28/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/02/2011
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: 12/20/2016 Patient Sequence Number: 1
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