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

Catalog Number 0112680

Device Problem Defective Device (2588)

Patient Problems Erosion (1750); Abnormal Vaginal Discharge (2123); Intermenstrual Bleeding (2665)

Event Type  Injury  

Manufacturer Narrative

At this time no conclusions can be made to what extent the bard/davol bard flat mesh device may have caused or contributed to the reported event.The medical records provided indicate that the patient underwent an additional surgery for erosion and vaginal discharge.Based on the limited information provided at this time, no conclusions can be made.Should additional information be provided a supplemental emdr will be submitted.Not returned.

Event Description

Per medical records: on (b)(6) 2007: the patient was diagnosed with vaginal prolapse, stress urinary incontinence and underwent an anterior/posterior vaginal repair with implant of a non davol avaulta mesh and a non davol uretex mesh.On (b)(6) 2010: the patient was diagnosed with recurrent apical vaginal prolapse and underwent an abd sacrocolpopexy with implant of a bard/davol bard flat mesh.Operative dictation notes the mesh was "trimmed" and sutured in place with no tension noted.On (b)(6) 2010: the patient was diagnosed with a suspected inadvertent cystotomy at recent abd sacrocolpopexy and underwent laparotomy with a cystotomy closure.There was no change to the bard flat mesh implant during this procedure.On (b)(6) 2012: the patient had an md office visit with complaints of vaginal discharge x 5 months and was diagnosed with bacterial vaginitis.A surgical pathology report has been provided in which some unspecified mesh was removed from the patient.There is no procedural report for this date, therefore, the mesh cannot be identified.On (b)(6) 2016: the patient had md office visit with complaints of foul smelling yellow vaginal discharge "for weeks" with intermittent spotting from vagina.Office notes indicate there are "4 areas of mesh erosion in the anterior vaginal wall with some sites spotting bright red blood and one rather large mesh erosion site on the posterior wall just inside the introitus (bard flat mesh).Prominent fish odor is present along with a moderate amount of yellow vaginal discharge.On (b)(6) 2016: the patient had an md office visit to follow up with the vaginal discharge.Md notes indicate there has been improvement with cream and antibiotics.As reported, the patient would like removal of the mesh from the vagina to prevent further infection.On (b)(6) 2016, (b)(6) 2016, & (b)(6) 2016-- office visits pertaining to the patient's mesh erosion.Surgery advised.No additional medical records provided beyond this date.

• 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: roxanne tidwell ; 100 crossings blvd.; warwick, RI 02886 ; 8015652659
• MDR Report Key: 8118533
• MDR Text Key: 128858699
• Report Number: 1213643-2018-04260
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016530
• UDI-Public: (01)00801741016530
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0112680
• Device Lot Number: HUSD1727
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/06/2018
• Initial Date FDA Received: 11/29/2018
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 57