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); Insufficient Information (3190)

Patient Problems Erosion (1750); Unspecified Infection (1930); Pain (1994)

Event Date 11/30/2010

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event.The medical records provided indicate the patient experienced infection, erosion and extrusion of mesh.Extrusion is listed as a known possible adverse reaction in the instructions-for-use.In regards to infection, the warning section of the instructions-for-use states "if an infection develops, treat the infection aggressively.The prosthesis may not have to be removed.An unresolved infection, however, may require removal of the prosthesis.¿ 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.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) 2009 - patient was diagnosed with uterocervical prolapse, pelvic muscle wasting and stress urinary incontinence.The patient underwent a total abdominal hysterectomy, bilat salpingo-oophorectomy, abdominal sacrocolpopexy with implant of a bard flat mesh and implant of a non bard davol "monarc" tot pubovaginal sling.On (b)(6) 2010 - patient had an md office exam and was noted to have excessive vaginal discharge and mesh exposure.The patient was prescribed oral antibiotics and a vaginal hormone cream.On (b)(6) 2010 - patient had an md office exam and was noted to have mesh projecting from the vaginal cuff.The projecting mesh was grabbed and partially excised.The patient was diagnosed with mesh extrusion, exposure and erosion from the vaginal cuff.She was given antibiotics and narcotic pain medication.On (b)(6) 2010 - patient was diagnosed with a vaginal cuff infection, dehiscence, pain and exposure of the mesh that was used for the abdominal sacrocolpopexy through the vaginal cuff.The patient underwent a partial excision of the bard flat mesh, excision of the infected vaginal cuff margin followed by resuturing of the vaginal cuff.

• 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: 5894899
• MDR Text Key: 52721348
• Report Number: 1213643-2016-00397
• 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: 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2013
• Device Catalogue Number: 0112680
• Device Lot Number: HUSL0426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 07/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2008
• 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