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

Catalog Number 0112640

Device Problems Defective Device (2588); Extrusion (2934); Insufficient Information (3190)

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

Event Date 08/26/2011

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event.Based on a review of the medical records provided it was reported the patient experienced extrusion, erosion, pain, recurrence, bleeding and infection.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 reported 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) 2003 - the patient was diagnosed with a uterine prolapse, vaginal vault prolapse, cystorectocele, stress urinary incontinence and a large enterocele.The patient underwent a two part procedure which included a total abdominal hysterectomy, vaginal salpingo-oophorectomy, lysis of adhesions, abd vaginal sacrospinous fixation and repair of enterocele with modified moschowitz procedure, implant of a bard flat mesh, cystoscopy, insertion of bilateral ureteral stents and a burch suspension procedure.On (b)(6) 2011 - patient presented with complaints of vaginal bleeding, foul odor vaginal discharge, multiple uti and was diagnosed with mesh erosion and stress urinary incontinence.The patient underwent excision of the bard flat mesh and implant of a non-bard davol "cook pubic bone sling." during this procedure the operative report details indicate that "the mesh was palpated and found to be extruding from the vaginal vault and with gentle traction the mesh was able to be extracted from the vaginal canal." it was reported the patient experienced pain, erosion of mesh, infection, recurrence, urinary/bowel problems and bleeding.

Manufacturer Narrative

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: (b)(6) 2003 - the patient was diagnosed with a uterine prolapse, vaginal vault prolapse, cystorectocele, stress urinary incontinence and a large enterocele.The patient underwent a two part procedure which included a total abdominal hysterectomy, vaginal salpingo-oophorectomy, lysis of adhesions, abd vaginal sacrospinous fixation and repair of enterocele with modified moschowitz procedure, implant of a bard flat mesh, cystoscopy, insertion of bilateral ureteral stents and a burch suspension procedure.On (b)(6) 2011 - patient presented with complaints of vaginal bleeding, foul odor vaginal discharge, multiple uti and was diagnosed with mesh erosion and stress urinary incontinence.The patient underwent excision of the bard flat mesh and implant of a non-bard davol "cook pubic bone sling." during this procedure the operative report details indicate that "the mesh was palpated and found to be extruding from the vaginal vault and with gentle traction the mesh was able to be extracted from the vaginal canal." it was reported the patient experienced pain, erosion of mesh, infection, recurrence, urinary/bowel problems and bleeding.

• 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: 5970039
• MDR Text Key: 55366115
• Report Number: 1213643-2016-00445
• 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,Followup
• Report Date: 08/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2005
• Device Catalogue Number: 0112640
• Device Lot Number: 43LKD059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 09/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2000
• 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: 54 YR
• Patient Weight: 95