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	Abdominal Pain (1685); Incontinence (1928); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on a review of medical records, it is unknown at this time to what extent the device may have caused or contributed to the reported event.A manufacturing review was performed which found no anomalies during the manufacturing process of the device.While the medical records indicate the patient experienced yeast infection approximately one year post implant of the eptfe mesh, the medical records do not indicate the infection to be related to the davol mesh implanted.In regards to infection however, the warning section of the instructions-for-use states "if an infection develops, treat the infection aggressively.The prosthesis may not have to be removed.An unresolved infection, however, may require removal of the prosthesis.¿ of note medical records that were provided did not make a direct allegation against the bard/davol mesh device.With the current information available, no definitive conclusion can be made as to the extent that the device may have caused or contributed to any post op complications.If additional event and/or evaluation information is obtained, a follow up mdr 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 to manufacturer.
Event or Problem Description
The following is based on a review of medical records provided to davol by the patient's attorney: on (b)(6) 2006 - the patient was diagnosed with a post hysterectomy vaginal vault prolapse with mixed urinary incontinence.The patient underwent an abdominal sacrocolpopexy, combined anterior and posterior repair using a davol ptfe mesh, implant of a non-davol suburethral mesh sling and cystoscopic suprapubic catheter placement.On (b)(6) 2007 and (b)(6) 2008 - the patient had an md office visits with complaints of an increase of vaginal discharge and urinary incontinence.The patient was prescribed an oral antifungal medication for a vaginal yeast infection and referred to consult with another urologist regarding reported incontinence.On (b)(6) 2008 - the patient was described with voiding dysfunction, urinary incontinence and urethral cyst.The patient underwent a cystourethroscopy, urethral cyst resection, cauterization of a bleeding base, suburethral and periurethral exploration and excision of scar tissue.On (b)(6) 2011 - the patient had an md office exam with complaints of pain at her left side, "ovary pain." on (b)(6) 2012 - the patient had an md office exam with complaints of left ovary being enlarged with occasional pain and aches in that area and has had issues in the past.Patient also complained of a "vaginal mass" and cannot have intercourse because it is "too painful." on (b)(6) 2012 - patient had an md office exam and was referred to have a colonoscopy performed as the pelvic sonogram was negative for any identifiable cause of her pain.
Additional Manufacturer Narrative
Addendum to the initial report.This supplemental report is being sent to provide the correct implant date and update the outcomes attributed to adv ev section.With the current information, no definitive conclusion can be made.If additional event and/or evaluation information, a follow up emdr will be submitted.

• 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: 6438777
• Report Number: 1213643-2017-00198
• Device Sequence Number: 10897913
• Product Code: FTL
• UDI-Device Identifier: 00801741031083
• UDI-Public: (01)00801741031083(17)110928(10)43IQD442
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Attorney
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2017

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: 09/28/2011
• Device Catalogue Number: 0117840
• Device Lot Number: 43IQD442
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/27/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2017
• Supplement Report FDA Received Date: 03/31/2017
• 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: Other; Required Intervention
• Patient Weight: 60