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

Catalog Number	0112670
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Fistula (1862); Prolapse (2475)
Date of Event	09/12/2016
Type of Reportable Event	Serious Injury
Additional 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 events.Adhesion is a known inherent risk of surgery and is listed in the instructions-for-use as a possible complication.Fistula formation is a known inherent risk of surgery and is listed in the instructions-for-use as a possible adverse reaction.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 or Problem Description
Per information provided by the patient's attorney, medical records & product id page: on (b)(6) 2000: the patient was diagnosed with vaginal prolapse, urinary incontinence and underwent an abd sacrocolpopexy with implant of a bard/davol flat mesh.On (b)(6) 2001: the patient was diagnosed with vaginal prolapse and underwent a revision procedure, anterior colporrhaphy, anterior repair, laparotomy and lysis of adhesions.On (b)(6) 2016: the patient was diagnosed with a colovaginal fistula and underwent an exploratory laparotomy with takedown and repair of colovaginal fistula, sigmoid colon, small bowel resection, removal of the bard/davol flat mesh, repair of incarcerated hernia and an incidental appendectomy.

• Brand Name: BARD FLAT 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: 8741441
• Report Number: 1213643-2019-05537
• Device Sequence Number: 19230239
• Product Code: FTL
• UDI-Device Identifier: 00801741016523
• UDI-Public: (01)00801741016523
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2000
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/27/2019

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 Catalogue Number: 0112670
• Device Lot Number: 43KJD293
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 06/27/2019
• 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: 78 YR