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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
Model Number 0112680
Device Problems Defective Device (2588); Extrusion (2934); Insufficient Information (3190)
Patient Problems Erosion (1750); Prolapse (2475); Intermenstrual Bleeding (2665); No Information (3190)
Event Date 10/27/2010
Event Type  Injury  
Manufacturer Narrative
Addendum to the previous report. This supplemental emdr is being sent due to additional information provided in the attorney's legal claim. It was alleged that the patient underwent an additional procedure which included excision of mesh approximately ten years post implant of the bard flat mesh. The patient's clinical course between the initial implant of the bard flat mesh and the excision procedure ten years later is unknown at this time as medical records were limited. A manufacturing review was performed which found no anomalies during the manufacturing process of the device. With the current information available no definitive conclusion can be made at this time. If additional event and/or evaluation information is obtained, this report will be updated.
 
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: (b)(6) 2000 - the patient was diagnosed with a cystocele, rectocele and enterocele. The patient underwent a bilateral salpingo-oophorectomy, abdominal sacrocolpopexy with implant of a bard flat mesh, anterior/posterior repair and an enterocele repair. On (b)(6) 2010 - the attorney alleged that the patient underwent additional surgical procedure which included excision of mesh due to vaginal cuff graft erosion. No medical records provided for this procedure. The attorney alleges the patient experienced erosion, extrusion, prolapse and bleeding.
 
Manufacturer Narrative
Currently, it is unknown whether the device may have caused or contributed to the reported event as no specific failure mode or patient injury was alleged. The medical records provided included the patient's implant operative report only. A manufacturing review was performed which found no anomalies during the manufacturing process of the device. With the current information available, no definitive conclusion can be made as to the extent that the device may have caused or contributed to any post op complications. 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 limited medical records and the attorney's legal claim provided to davol by the patient's attorney: on (b)(6) 2000 - the patient was diagnosed with a cystocele, rectocele and enterocele. The patient underwent a bilateral salpingo-oophorectomy, abdominal sacrocolpopexy with implant of a bard flat mesh, anterior/posterior repair and an enterocele repair. The attorney alleges the patient experienced an unspecified adverse outcome associated to the use of the device.
 
Manufacturer Narrative
Addendum to the initial report. This supplemental emdr is being sent to provide the correct product identifier as well as an updated udi number. With the current information, no conclusion can be made. If additional event and/or evaluation information is obtained, a follow up emdr will be submitted.
 
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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 Key6487456
MDR Text Key161290047
Report Number1213643-2017-00236
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,Followup,Followup
Report Date 07/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/28/2004
Device Model Number0112680
Device Catalogue Number0112670
Device Lot Number43DJD264
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 Received06/26/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/29/1999
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: 04/12/2017 Patient Sequence Number: 1
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