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

Model Number	0117008
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Erosion (1750); Incontinence (1928); Urinary Tract Infection (2120)
Date of Event	02/26/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Currently, it is unknown to what extent the device may have caused or contributed to the reported event.Based on the medical records provided it was reported that seven years post implant of the bard soft mesh the patient experienced recurrent urinary tract infections and urinary incontinence.With the information provided it is unclear if the recurrent urinary tract infections were related to the bard soft mesh previously implanted.Infection is listed as a known inherent risk of surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication.If additional event and/or evaluation information is obtained, a follow up 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 to manufacturer.
Event or Problem Description
The following is based on a review of medical records provided to davol by the patient's attorney: (b)(6) 2007 - the patient was diagnosed with stress incontinence and underwent a cystoscopy procedure and mid-urethral sling implant using a bard soft mesh.(b)(6) 2014 - the patient presented with recurrent urinary tract infections and urinary incontinence.An in office cystoscopy noted the patient had anterior erosion of mesh (davol soft).The patient was diagnosed with intraurethral mesh erosion and underwent partial excision of the bard soft mesh followed by cystoscopy.Per operative report details "the mesh (davol soft) erosion was noted anteriorly very distal to the urethra.This was excised laterally to remove the entire portion of mesh that was intraurethral.".
Additional Manufacturer Narrative
Addendum to the previous information.This supplemental emdr is being sent to correct the date of manufacture for the device.A manufacturing review was performed which found that the device provided was manufactured to specification.With the current information available no definitive conclusion can be made.If additional event and/or evaluation information is obtained, this report will be updated.

• Brand Name: SOFT MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 7175921
• Report Number: 1213643-2018-00037
• Device Sequence Number: 1786259
• Product Code: FTL
• UDI-Device Identifier: 00801741030857
• UDI-Public: (01)00801741030857
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2011
• Device Model Number: 0117008
• Device Catalogue Number: 0117008
• Device Lot Number: DAQG0007
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2017
• Supplement Date Received by Manufacturer: 05/15/2018
• Initial Report FDA Received Date: 01/09/2018
• Supplement Report FDA Received Date: 05/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 117