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

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.

• Brand Name: BARD FLAT MESH
• Type of Device: SURGICAL 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 Key: 6487456
• MDR Text Key: 161290047
• Report Number: 1213643-2017-00236
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• 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 Received: 04/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 04/28/2004
• Device Model Number: 0112680
• Device Catalogue Number: 0112670
• Device Lot Number: 43DJD264
• 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 Received: 06/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/1999
• 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