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

Model Number	0117009
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Erosion (1750); Urinary Tract Infection (2120); Prolapse (2475); Bowel Perforation (2668)
Date of Event	10/17/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Currently, it is unknown to what extent the device may have caused or contributed to the reported event.Based on the information provided, it was reported that the patient experienced recurrent uti's and mesh erosion.It was also reported that the patient experienced adhesions on the patient's right side, however, there was no indication that the adhesions were directly to the mesh implanted in the patient.Adhesions and infection are known inherent risks of surgery and are identified in the adverse reaction section of the instructions-for-use as a possible complication.A manufacturing review was performed which found no anomalies during the manufacturing process of the device.If additional event and/or evaluation information is obtained, this report will be updated.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: (b)(6) 2010 - the patient was diagnosed with vaginal prolapse, stress urinary incontinence, urethral mobility, frequency and urgency.The patient underwent a sacrocolpopexy with implant of a bard soft mesh and a non-bard davol "monarc" urethral sling.(b)(6) 2012 - the patient was diagnosed with bladder foreign body, abdominal adhesions, stress urinary incontinence and vaginal prolapse.The patient underwent abdominal exploration, lysis of adhesions, revision/removal of the bard soft mesh and revision of the non-bard davol mid-urethral sling.Per the operative indication " the patient is a (b)(6) female who is status post abd sacrocolpopexy, who was having recurrent urinary tract infections and abd discomfort underwent cystoscopy.Office cystoscopy demonstrated an area on the right lateral wall, where within the bladder mucosa you could see filaments of the mesh that was used for her colpopexy and just over the top of that there were few small bladder stones.She is complaining of right inguinal pain and right lower abd quadrant pain.".
Additional Manufacturer Narrative
This is an addendum to the initial mdr to document additional outcomes attributed to adverse event based on the additional medical treatments/hospitalization and general patient outcomes as alleged by the patient.Currently it is unknown to what extent the bard soft mesh device may have caused or contributed to the reported event.It was reported that the patient experienced recurrent uti's and mesh erosion.It was also reported that the patient experienced adhesions on the patient's right side; however, there was no indication that the adhesions were directly to the mesh implanted in the patient.The patient alleges "abscess in colon/bowel and fistulas that are growing together." adhesions are known inherent risks of surgery and adhesions and fistula are identified in the adverse reaction section of the instructions-for-use as a possible complication.Regarding infection 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.¿ a manufacturing review was performed which found no anomalies during the manufacturing process of the device.Based on the information provided at this time, no conclusions can be made.Should additional information be provided a supplemental emdr will be submitted.
Event or Problem Description
As reported on 01/08/2018, the following is based on a review of medical records provided to davol by the patient's attorney: (b)(6) 2010 - the patient was diagnosed with vaginal prolapse, stress urinary incontinence, urethral mobility, frequency and urgency.The patient underwent a sacrocolpopexy with implant of a bard soft mesh and a non-bard davol "monarc" urethral sling.(b)(6) 2012 - the patient was diagnosed with bladder foreign body, abdominal adhesions, stress urinary incontinence and vaginal prolapse.The patient underwent abdominal exploration, lysis of adhesions, revision/removal of the bard soft mesh and revision of the non-bard davol mid-urethral sling.Per the operative indication " the patient is a 70 year old female who is status post abd sacrocolpopexy, who was having recurrent urinary tract infections and abd discomfort underwent cystoscopy.Office cystoscopy demonstrated an area on the right lateral wall, where within the bladder mucosa you could see filaments of the mesh that was used for her colpopexy and just over the top of that there were few small bladder stones.She is complaining of right inguinal pain and right lower abd quadrant pain." this is an addendum to the initial mdr to document additional medical information and general patient outcomes as provided by the patient.From 2012 to present (2018), the patient alleges being seen by her doctor for infections, abscess in colon/bowel and fistulas that are growing together.(b)(6) 2018: the patient was hospitalized for abscesses, fistulas, infections and diverticulitis.Patient alleges bodily injuries resulted from the implant of the bard/davol soft mesh: ¿mesh erosion, abdominal pelvic pain, infection, painful intercourse and vaginal bleeding.¿ patient alleges before implant of the bard/davol soft mesh product she had "an active lifestyle.¿ as reported after the implant of the pelvic mesh product (s), patient reports ¿had a severe infection after the revision surgery that left me hospitalized for a week.After that my body has not been the same.I have infections and fistulas and more severe incontinence and pain than before the surgery.¿ alleged patient suffered from adhesions, bowel obstruction, bowel perforation, chronic constipation, enterocele, ibs, colitis, diverticulitis, dyspareunia, polymyalgia pneumatic, severe infection after revision, fistulas, peritonitis/sepsis, bladder and vaginal infections, severe pelvic pain, bowel pain, urinary incontinence, urinary retention and wound healing problems after implant of the bard/davol 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: 7173358
• Report Number: 1213643-2018-00024
• Device Sequence Number: 1448172
• 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: 2010
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2018

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: 05/28/2015
• Device Model Number: 0117009
• Device Catalogue Number: 0117009
• Device Lot Number: HUUD1818
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2017
• Supplement Date Received by Manufacturer: 04/16/2018
• Initial Report FDA Received Date: 01/08/2018
• Supplement Report FDA Received Date: 05/03/2018
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 71