MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233; AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Irritation (1941); Chills (2191); Discomfort (2330)

Event Type  Injury  

Event Description

It was reported by the patient's attorney that as a result of having the product implanted, the patient has experienced pain, nausea, urinary tract infection, urinary urgency, urinary frequency, fecal incontinence, nocturia, incomplete emptying of bladder, vaginal bruising, atrophic vaginitis, cystitis (inflammation), stricture, vaginal discharge, cracking of skin on genitalia, extrusion, infection, recurrence, additional surgical interventions, pelvic organ prolapse, increased urinary stream, discomfort between the rectum and vagina, acute cystitis, dysuria, lower abdominal cramping, small rectocele, occasional incomplete emptying, left labial minora with small area of bruising, eroded mesh at the vaginal apex, stage one vaginal prolapse, moderate atrophic vaginitis, slight sense of stool trapping, minimal recurrent cystocele between two and three, mesh erosion on the proximal anterior wall, bladder issues, pelvic relaxation symptoms, digital defecation, pressure in vaginal and rectal area when standing, introitus irritation, pelvic pressure, mesh eroded through top of vagina at cervical vaginal junction, rectal pain, mesh erosion at cuff, chills, backache, stricture above the cervix, cracking of the skin noted at the posterior fourchette from hyperkeratosis induced by the discharge from the eroded graft, yellow discharge around the graft, and multiple nonsurgical interventions.

• Type of Device: AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8700176
• MDR Text Key: 148146386
• Report Number: 1018233-2019-03125
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/13/2019,06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/13/2019
• Distributor Facility Aware Date: 05/15/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/13/2019
• Date Manufacturer Received: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 54