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

Catalog Number	0114510
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
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) 2008 the patient was diagnosed with vaginal vault prolapse, stress urinary incontinence and underwent a laparoscopic abd sacrocolpopexy with implant of a bard/davol flat mesh, laparoscopic burch procedure and cystourethroscopy.Per the operative report details, "a piece of gore-tex (davol reconix) graft material, 1 mm thick, 4 cm wide and 10 cm long was inserted into the peritoneal cavity and the distal end of the graft was sutured to the posterior apex of the vagina with 8 sutures.The proximal portion of the graft was tacked to the sacral promontory with pro tacker." attorney alleges unspecified adverse patient outcomes associated with use of device.

• Brand Name: RECONIX
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 9176789
• Report Number: 1213643-2019-09914
• Device Sequence Number: 2762881
• Product Code: FTL
• UDI-Device Identifier: 00801741011832
• UDI-Public: (01)00801741011832
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K003906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/10/2019

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: 0114510
• Device Lot Number: BRQE6129
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 10/10/2019
• 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: Other