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

Catalog Number 0112660

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

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

Event Date 08/23/2007

Event Type  Injury  

Manufacturer Narrative

Currently it is unknown to what extent the bard/davol bard flat mesh contributed to the patient's reported post-operative complications.The information provided indicates that device was adhered to the patient's bowel and bladder.Adhesions are a known risk of surgery and is listed in the instructions-for-use as a possible complication.As stated in the contraindications section of the instructions-for-use; "literature reports there may be a possibility for adhesion formation when [the] mesh is placed in direct contact with the bowel or viscera." medical records provided have been limited to the implant operative report, implant tracking log, and event operative report.A sample was not returned for further evaluation.Based on the limited information provided, no conclusions can be made between the bard/davol device used to treat the patient and any problem with the device.Should additional information be provided, a supplemental emdr 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.

Event Description

As reported by the patient's attorney via the implant operative report, implant tracking log and event operative report: on (b)(6) 2005 - the patient underwent a 2-part procedure which included an abd sacral urethropexy with implant of a bard/davol bard flat mesh, implant of a pubovaginal sling using a non-bard/davol ¿gynecare¿ sling, urethra cystoscopy, anterior resection and rectopexy.Per the implant operative report details, ¿a piece of polypropylene mesh (davol flat) was then appropriately trimmed to attach to the rectovaginal fascial sutures.The decision was made to use two separate strips of polypropylene mesh which were trimmed in a curved fashion.The two strips of polypropylene mesh (davol flat) were then attached anteriorly using two rows of sutures of ethibond to the pubocervical fascia.Non-bard/davol seprafilm was placed over all of the peritoneal sites including the limbs of the sacral colpopexy graft at the sacrum.¿ on (b)(6) 2007 - the patient was diagnosed with pelvic pressure, bowel dysfunction, rectocele and underwent a total abd hysterectomy with lysis of adhesions and a posterior repair.Per the operative report details, the bard/davol bard flat mesh was noted to be adherent to the patient¿s uterus, bowel, and bladder.The surgeon was able to separate these from the mesh without any issue.As noted, the surgeon placed a non-bard/davol seprafilm over the areas that had been adherent to the mesh to prevent further adhesion formation.

• 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: laura abrams ; 100 crossings blvd.; warwick, RI 02886 ; 4018258605
• MDR Report Key: 7643829
• MDR Text Key: 112545823
• Report Number: 1213643-2018-02255
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016516
• UDI-Public: (01)00801741016516
• 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: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2009
• Device Catalogue Number: 0112660
• Device Lot Number: 43JOD013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2004
• 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): Required Intervention
• Patient Age: 26 YR