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

Catalog Number UNKAA030

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

Patient Problems Adhesion(s) (1695); Pain (1994); Prolapse (2475)

Event Date 08/02/2001

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event. The medical records indicate the patient experienced adhesions and erosion. Adhesions are listed as a known adverse reaction in the instructions-for-use. While the medical records indicate a post operative diagnosis of erosion, there is no description of this in the operative details provided. Without a lot number a review of the manufacturing records could not be conducted. Additionally, no product was returned for evaluation. With the currently available information, no conclusion can be drawn. 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) 2001 - the patient was diagnosed with stress urinary incontinence, symptomatic enterocele and colonic bowel adhesions. The patient underwent a marshall-marchetti-krantz procedure, abdominal repair of enterocele, marlex mesh graft (bard / davol flat) on (b)(6) 2001 - the patient was diagnosed with severe pelvic pain at the site of the "marlex" mesh sacrocolpopexy and its attachment to the vagina and partial erosion. The patient underwent explant of the "marlex" and a vaginal vault suspension and enterocele repair with a modified mccall culdoplasty. At this time the patient had ureteral stents placed on (b)(6) 2006 - the patient had an md office visit with complaints of prolapse more pronounced with standing. There was concern to pursue surgery as the patient had severe chronic pain related issues and adhesions from previous surgeries. On (b)(6) 2007 - patient had an md office visit with continued complaints of pelvic pain and urgency symptoms, very similar to the pain experienced since 2001. Patient has symptoms consistent with pelvic pain syndrome. Md does not see an indication for surgery at this time. Patient treated with prescriptions and educational handouts.

• 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: 6171755
• MDR Text Key: 62313948
• Report Number: 1213643-2016-00572
• 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: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNKAA030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: Hospital
• Date Manufacturer Received: 11/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 12/13/2016 Patient Sequence Number: 1