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

Catalog Number 486101

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

Patient Problems Hemorrhage/Bleeding (1888); Abnormal Vaginal Discharge (2123); Injury (2348)

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: ¿potential adverse reactions are those typically associated with surgically implantable materials, including 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." 2348, 2993, 1888, 2123 = "nl".

Event Description

The patient's attorney alleged a deficiency against the device.Per additional information received, the patient has experienced scant, spotting postmenopausal type vaginal bleeding as well as occasional vaginal discharge that seems to be aggravated by sexual activity and vaginal intercourse, urinary frequency associated with urgency, occasional incontinence, fecal urgency and occasional fecal incontinence, mesh exposure, small piece of granulation tissue, irritative type symptom as well with intercourse, mesh erosion, vaginal drainage and discharge, voiding dysfunction, prolapse, urinary tract infections, stress incontinence, 2 or 3 spots on anterior vagina, near cervix, fistula, and vaginal erosion.The patient required additional surgical and non-surgical interventions.

• Brand Name: AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - ANTERIOR
• Type of Device: AVAULTA PLUS® BIOSYNTHETIC SUPPORT SYSTEM - ANTERIOR
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 11073800
• MDR Text Key: 223732306
• Report Number: 1018233-2020-06396
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2010
• Device Catalogue Number: 486101
• Device Lot Number: CVSL0009
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 5 MO
• Event Location: Hospital
• Date Manufacturer Received: 12/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 83