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

Catalog Number 0112720

Device Problems Defective Device (2588); Insufficient Information (3190)

Patient Problem 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 op report and 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) 2002 - the patient was diagnosed with a vaginal prolapse with a cystocele, stress urinary incontinence and intestinal adhesions secondary to previous surgery.The patient underwent an exploratory laparotomy, vaginal vault sacrocolpopexy with implant of a davol flat mesh, retropubic urethropexy by modified burch procedure, bilateral salpingo-oophorectomy and a modified moskowitz procedure.The attorney alleges the patient experienced an unspecified adverse outcome associated to the use of the device.

• 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: 6199761
• MDR Text Key: 63128579
• Report Number: 1213643-2016-00587
• 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
• Report Date: 12/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2006
• Device Catalogue Number: 0112720
• Device Lot Number: 43DLD057
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 12/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2001
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other