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

Model Number 0117009

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

Patient Problems Erosion (1750); Unspecified Infection (1930); Internal Organ Perforation (1987)

Event Date 01/14/2010

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event.The attorney's legal claim alleges the patient experienced pain, erosion, extrusion, urinary/bowel problems, dyspareunia, vaginal scarring and organ perforation.The medical records provided do no support the attorney's allegation of organ perforation and mesh extrusion, however, extrusion is listed as a known possible adverse reaction in the instructions-for-use.The medical records provided do indicate the patient experienced infection, wound dehiscence and erosion.In regard to infection, the warning section of the instructions-for-use states "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the device." based on the implant operative report, it appears a quantity of two soft mesh devices were used and it appears were fashioned together for the repair.It can not be determined at this time if only one soft mesh or both were excised during the excision procedures.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.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.A second emdr has been submitted to address the second soft mesh implanted during the same procedure.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.Device not returned to manufacturer.

Event Description

The following is based on a review of medical records provided to davol by the patient's attorney: (b)(6) 2009 - the patient was diagnosed with recurrent pelvic organ prolapse with left ovarian cyst, pelvic pain, extensive pelvic and abdominal adhesions involving the bowel omentum.The patient underwent an abdominal sacrocolpopexy with implant of two bard soft meshes, bilateral salpingo-oophorectomy, rectocele repair, extensive lysis of adhesions and cystoscopy.Postoperatively, the patient experienced wound dehiscence, cellulitis and wound infection.The patient was treated with wet-to-dry dressing changed and antibiotics.Per implant op details "nine sutures of pds were taken through the posterior vagina wall.These sutures were then attached to the bard soft mesh.The 2 leaves of mesh (davol soft 1 & 2) were then laid in the pelvis up toward the sacral promontory.Three sutures of ethibond were taken through the anterior spinal ligament and used to attach the cephalad portion of the mesh." (b)(6) 2009 - the patient was diagnosed with vagina mesh erosion.The patient underwent a partial excision of the area of erosion noted on the anterior vaginal apex with oversewing of vagina.(b)(6) 2010 - the patient experienced vaginal mesh erosion in the right anterior vaginal apex.The patient underwent aggressive estrogen vaginal cream therapy; but continued to have a small area of mesh eroding through.The patient underwent another partial excision.(b)(6) 2016 - the patient had md office exams and was diagnosed with erosion of the "posterior mesh (1 & 2) likely from cuff suspension." per the md notes, the patient was advised that surgical intervention would likely not resolve her problem and make it worse.The attorney's legal claim alleges the patient experienced pain, erosion, extrusion, urinary/bowel problems, dyspareunia, vaginal scarring and organ perforation.

• Brand Name: SOFT 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: 6961614
• MDR Text Key: 89727546
• Report Number: 1213643-2017-00709
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741030864
• UDI-Public: (01)00801741030864(17)140128(10)HUSL1191
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052155
• 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: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2014
• Device Model Number: 0117009
• Device Catalogue Number: 0117009
• Device Lot Number: HUSL1191
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2009
• 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): Life Threatening; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 97