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

Catalog Number	0117840
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Urinary Tract Infection (2120); No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Currently it is unknown if and to what extent the bard/davol device may have contributed to the patient's adverse outcome.As the patient had a prior medical history of kidney stones, it is unclear if the reported urinary problems are associated with the bard/davol mesh or if this is the outcome of the kidney stones.No sample was returned for evaluation and medical records provided have been limited to the implant operative report and implant tracking log.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Based on the limited information provided no conclusions can be made between the reported post-operative complications and the bard/davol device used to treat the patient.Should additional information be provided, a supplemental emdr will be submitted.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.Not returned.
Event or Problem Description
As reported by the patient's attorney, implant op report & implant tracking log: on (b)(6) 2006, the patient was diagnosed with vaginal wall prolapse, mixed urinary incontinence and underwent an abd sacrocolpopexy with implant of a bard/davol ptfe mesh, combined anterior-posterior repair, implant of a non-bard/davol synthetic "uretex" pubovaginal sling and insertion of a suprapubic catheter.Per the implant operative report details, "we then placed two pieces of teflon mesh (ptfe), one to the anterior aspect of the vagina and one to the posterior aspect.The two pieces of the mesh were secured to the vaginal apex with ethibond suture and the two pieces to the mesh were secured together.We then attached the mesh to the sacral promontory using ethibond suture." on (b)(6) 2012, the patient underwent cystoscopy which is noted to have been "uneventful." office visit notes indicate the patient to have experienced blood in the urine along with occasional leakage of urine after coughing as well as after initial urination.Patient treated for a uti.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: 7683753
• Report Number: 1213643-2018-02393
• Device Sequence Number: 1398972
• 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: 2006
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date (Section B): 07/12/2018

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: 05/28/2011
• Device Catalogue Number: 0117840
• Device Lot Number: 43EQD227
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2018
• Initial Report FDA Received Date: 07/12/2018
• 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