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

Catalog Number 486201

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

Patient Problems Abdominal Pain (1685); Autoimmune Disorder (1732); Erosion (1750); Diarrhea (1811); Hemorrhage/Bleeding (1888); Pain (1994); Urinary Tract Infection (2120); Urinary Frequency (2275); Injury (2348); Arthralgia (2355); Disability (2371); Prolapse (2475); Hematuria (2558); Constipation (3274); Dyspareunia (4505); Urinary Incontinence (4572); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

The sample was not returned.The finished product met all specifications prior to being released for general distribution.The instructions for use which accompanies all devices currently addresses potential risks associated with surgically implanted materials.The instructions for use states in the adverse events: hematoma, seroma, mucosal or visceral erosion, infection, inflammation, sensitization, dyspareunia, scarification and contraction, fistula formation, extrusion and recurrence of vaginal wall prolapse.Perforations or lacerations of vessels, nerves, bladder, bowel, rectum, or any viscera may occur during needle passage.(b)(4).

Event Description

It was reported by the patient's attorney that as a result of having the product implanted the patient has experienced pain, suffering, disability, impairment, loss of enjoyment of life, inability to engage in chosen and necessary activities and/or economic damages.

Event Description

Per additional information received on 04jun2021, the patient experienced vaginal mesh erosion, pain, dyspareunia, urge incontinence, urinary frequency, nocturia, bleeding, cystocele, enterocele, rectocele, recurrent vaginal pain, urinary incontinence, uterine prolapse, vaginal atrophy, incomplete emptying, frequent urinary tract infections, hematuria, kidney stones, kidney problems, vaginal pressure, constipation, diarrhea, autoimmune disease, leg swelling, arthralgias and required additional surgical and non-surgical interventions.

Manufacturer Narrative

1750, 2475, 2120="l" 2275, 1888, 1685, 2558, 3274="nl".

• Brand Name: AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - POSTERIOR
• Type of Device: AVAULTA PLUS® BIOSYNTHETIC SUPPORT SYSTEM - POSTERIOR
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9832229
• MDR Text Key: 188334303
• Report Number: 1018233-2020-01812
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K082571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 06/11/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2008
• Device Catalogue Number: 486201
• Device Lot Number: CVRI0042
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 2 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/10/2020
• Initial Date FDA Received: 03/13/2020
• Supplement Dates Manufacturer Received: 06/04/2021
• Supplement Dates FDA Received: 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALIGN® TO URETHRAL SUPPORT SYSTEM - HOOK.; UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 91