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

Catalog Number 0112680

Device Problems Defective Device (2588); Extrusion (2934)

Patient Problems Erosion (1750); Internal Organ Perforation (1987); Prolapse (2475)

Event Date 03/20/2007

Event Type  Injury  

Manufacturer Narrative

Addendum to the previous report. This supplemental emdr is being sent due to the allegation of organ perforation which is considered a life-threatening outcome attributed to adverse event. Mesh extrusion was also alleged in the attorney's legal claim, mesh extrusion is listed as a known adverse reaction in the instructions-for-use. To date no medical records have been provided which indicate any type of organ perforation experienced by the patient. A manufacturing review was performed which found no anomalies during the manufacturing of the device. With the current information available no definitive conclusion can be made. If additional event and/or evaluation information is obtained, a follow up emdr will be submitted. Updated fields.

Event Description

The following is based on a review of medical records and the attorney's legal claim provided to davol by the patient's attorney: on (b)(6) 2002 - the patient underwent a total abdominal hysterectomy, bilateral salpingo-oophorectomy and adhesiolysis. No additional details provided. On (b)(6) 2003 - the patient was diagnosed with a cystocele and underwent implant of a pubovaginal sling using a bard flat mesh, cystocele repair and open suprapubic tube placement followed by cystoscopy. On (b)(6) 2007 - the patient was diagnosed with foreign body in her vagina. The patient was noted to have a "less than 1cm vaginal mesh (davol flat) erosion at the apex of the anterior vaginal wall. " the patient underwent excision of a greater than a 1x1 cm piece of flat mesh. The attorney's legal claim alleges the patient experienced pain, extrusion, prolapse, dyspareunia and organ perforation.

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event. A manufacturing review was performed and found no anomalies during the manufacturing process. With the current information available no definitive conclusion can be made. 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 provided to davol by the patient's attorney: on (b)(6) 2002 - the patient underwent a total abdominal hysterectomy, bilateral salpingo-oophorectomy and adhesiolysis. No additional details provided. On (b)(6) 2003 - the patient was diagnosed with a cystocele and underwent implant of a pubovaginal sling using a bard flat mesh, cystocele repair and open suprapubic tube placement followed by cystoscopy. On (b)(6) 2007 - the patient was diagnosed with foreign body in her vagina. The patient was noted to have a "less than 1cm vaginal mesh (davol flat) erosion at the apex of the anterior vaginal wall. " the patient underwent excision of a greater than a 1x1 cm piece of flat mesh.

• 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: francesca santamaria ; 100 crossings blvd.; warwick, RI 02886 ; 4018258538
• MDR Report Key: 6390731
• MDR Text Key: 194977205
• Report Number: 1213643-2017-00166
• 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: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 08/30/2008
• Device Catalogue Number: 0112680
• Device Lot Number: 43HND045
• 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: 04/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2003
• 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: 03/09/2017 Patient Sequence Number: 1