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

Model Number	0117008
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Prolapse (2475)
Date of Event	08/27/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient appears to have a complex medical history.There is no connection that can be made between the problems experienced by the patient and the davol soft mesh used to treat her in 2012.Review finds no other complaints have been reported to date for this manufacturing lot (huwd1245).If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.Not returned to manufacturer.
Event or Problem Description
The following is based on a review of medical records provided to davol by the patient's attorney: (b)(6) 2012 - the patient was diagnosed with a total vault prolapse with a large cystocele.The patient underwent a laparotomy, open sacrocolpopexy with implant of a bard soft mesh, repair of vaginal vault opening and burch bladder suspension followed by cystoscopy.(b)(6) 2013 - the patient had an md office visit where the patient complained of a vaginal bulge or pressure and underwent office cystoscopy.The patient was diagnosed with pelvic prolapse.(b)(6) 2013 - the patient was diagnosed with symptomatic pelvic prolapse and underwent a cystocele repair with implant of two non-bard davol grafts and a non bard davol mesh, sacrospinous ligament vaginal vault suspension and cystoscopy.There was no mention of any visualization or involvement of the previously implanted bard soft mesh.

• Brand Name: 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: 7150794
• Report Number: 1213643-2017-01119
• Device Sequence Number: 19203887
• Product Code: FTL
• UDI-Device Identifier: 00801741030857
• UDI-Public: (01)00801741030857
• 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: 2012
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date (Section B): 12/28/2017

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: 05/28/2017
• Device Model Number: 0117008
• Device Catalogue Number: 0117008
• Device Lot Number: HUWD1245
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2017
• Initial Report FDA Received Date: 12/28/2017
• 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: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 79