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 Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Information is limited at this time.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) 2013 the patient was diagnosed with a vaginal vault prolapse, inclusion cyst and underwent a robotic assisted laparoscopic abd sacrocolpopexy with implant of a bard/davol flat mesh and excision of inclusion cyst.Per the operative report details, "the mesh (davol flat) was tailored to cover the cuff.Once done, it was secured to the cuff using ethibond sutures.Attention was then placed to the sacral promontory.The retroperitoneum was then incised to make a tunnel to close over the mesh.Once this was done, the mesh (davol flat)was tensioned appropriately.The autosuture tacker was used to fix 2 titanium helical fasteners to the sacral promontory." attorney alleges unspecified adverse patient outcomes associated with use of device.

• 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: 8713184
• Report Number: 1213643-2019-05221
• Device Sequence Number: 14064994
• 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: 2013
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/19/2019

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 Expiration Date: 03/28/2018
• Device Catalogue Number: 0112670
• Device Lot Number: HUXB1559
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 06/19/2019
• 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