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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); Material Protrusion/Extrusion (2979); Insufficient Information (3190)
Patient Problems Fistula (1862); Unspecified Infection (1930); Internal Organ Perforation (1987); No Information (3190)
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 and medical records were limited to the patient's implant tracking log only. 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.
 
Event Description
The following is based on a review of limited medical records and the attorney's legal claim provided to davol by the patient's attorney: on (b)(6) 2011 - patient underwent an abdominal sacrocolpopexy with implant of a bard/davol soft mesh and excision of an unknown "vaginal mesh. " the attorney alleges the patient experienced an unspecified adverse outcome associated to the use of the 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
steven figueroa
100 crossings blvd.
warwick, RI 02886
4018258460
MDR Report Key5467566
MDR Text Key39287557
Report Number1213643-2016-00078
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 11/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/29/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2016
Device Catalogue Number0117009
Device Lot NumberHUVA1053
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received10/16/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/26/2011
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: 02/29/2016 Patient Sequence Number: 1
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