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

Catalog Number	0117840
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The cause of the patient's post-operative complications cannot be determined at this time.Specific patient complications were not provided.Although there is no known medical intervention that has been reported at this time, a serious patient injury related to the use of the bard/davol ptfe mesh is alleged.At this time, there is no known malfunction of the device as reported.A review of the manufacturing records has been conducted and found the device was manufactured to specification.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, implant op report & product id page.On (b)(6) 2005 the patient was diagnosed with vaginal wall prolapse, pelvic pain, mixed urinary incontinence and underwent an abd sacrocolpopexy with implant of a bard/davol ptfe mesh, bilat salpingo-oophorectomy, combined anterior/posterior repair, implant of a non davol uretex pubovaginal sling followed by cystoscopy and suprapubic catheter placement.Per the implant operative report details, "the peritoneum was dissected off of the vaginal apex.We then placed two separate pieces of teflon mesh, one posteriorly and one anteriorly to provide support to the vaginal apex.We then dissected laterally to the rectum and secured the mesh tot he sacrum." attorney alleges unspecified adverse patient outcomes associated with use of device.

• Brand Name: PTFE 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: 8140095
• Report Number: 1213643-2018-04461
• Device Sequence Number: 950219
• Product Code: FTL
• UDI-Device Identifier: 00801741031083
• UDI-Public: (01)00801741031083
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/06/2018

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: 11/28/2009
• Device Catalogue Number: 0117840
• Device Lot Number: 43KOD180
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 12/06/2018
• 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