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

Catalog Number	0117009
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Prolapse (2475)
Date of Event	06/07/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges additional medical treatment for a vaginal bulge and was diagnosed with a rectocele.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Should additional information be provided a supplemental emdr will be submitted.Not returned.
Event or Problem Description
The following was alleged by the patient's attorney, medical records & product id page: on (b)(6) 2011 the patient was diagnosed with pelvic organ prolapse and underwent a robotic assisted sacrocolpopexy with implant of a bard/davol soft mesh followed by cystoscopy.About 4 months later on (b)(6) 2011 the patient had a post op visit and reported a vaginal bulge.Patient was examined and was diagnosed with a rectocele.Patient was recommended an additional outpatient procedure for repair.

• Brand Name: BARD 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: 8769162
• Report Number: 1213643-2019-05820
• Device Sequence Number: 1832569
• Product Code: FTL
• UDI-Device Identifier: 00801741030864
• UDI-Public: (01)00801741030864
• 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: 2011
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/08/2019

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: 09/28/2015
• Device Catalogue Number: 0117009
• Device Lot Number: HUUI1416
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 07/08/2019
• 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; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 89