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

Catalog Number	0117840
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Currently, it is unknown whether the device may have caused or contributed to the reported event as no device specific failure mode or patient injury was alleged.The medical records provided were limited to the patient's implant tracking log and implant operative report only.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 as to the extent the mesh may have caused or contributed to any post op complications.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 or Problem Description
The following is based on a review of limited medical records and the attorney's legal claim provided to davol by the patients attorney: on (b)(6) 2005 - the patient was diagnosed with a post obstructive vaginal vault prolapse, mixed urinary incontinence and pelvic pain.The patient underwent an abdominal sacrocolpopexy, combined anterior/posterior repair with implant of a bard ptfe mesh, bilateral salpingo-oophorectomy, implant of a non davol suburethral sling followed by cystoscopy with suprapubic catheter placement.The attorney alleges the patient experienced an adverse outcome associated to the use of the device.

• Brand Name: PTFE 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: 6438780
• Report Number: 1213643-2017-00197
• Device Sequence Number: 512136
• Product Code: FTL
• UDI-Device Identifier: 00801741031083
• UDI-Public: (01)00801741031083(17)100728(10)43GPD203
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date (Section B): 03/28/2017

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: 07/28/2010
• Device Catalogue Number: 0117840
• Device Lot Number: 43GPD203
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2017
• Initial Report FDA Received Date: 03/28/2017
• 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: Other