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

Model Number 486010

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

Patient Problems Anemia (1706); Bacterial Infection (1735); Erosion (1750); Calcium Deposits/Calcification (1758); Chest Pain (1776); Cyst(s) (1800); Ecchymosis (1818); Fatigue (1849); Micturition Urgency (1871); Hematoma (1884); Hemorrhage/Bleeding (1888); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Internal Organ Perforation (1987); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Hernia (2240); Anxiety (2328); Neck Pain (2433); Prolapse (2475); Hematuria (2558); Blood Loss (2597); Osteopenia/ Osteoporosis (2651); Dysuria (2684); Foreign Body In Patient (2687); Fibrosis (3167); Constipation (3274); Dyspareunia (4505); Urinary Incontinence (4572); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

Corrected data highlighted in yellow.

Event Description

Per additional information received, the patient has experienced chronic bladder infections, bladder leakage, reimplantations, loss of consortium, postoperative hemorrhage requiring ligation of vaginal cuff bleeder and a blood transfusion, postoperative anemia, gardnerella, dysfunctional voiding, stranguria, incomplete emptying, recurrent cystocele, exposure requiring 5 excision surgeries, ecchymoses around the buttocks, subfascial hematoma, recurrent stress incontinence requiring sling placement times 2, recurrent urinary tract infections, delayed healing of vaginal incision, symptomatic rectocele requiring repair with mesh, vaginal wall prolapse, chronic cystitis, dysuria, and intrinsic sphincter deficiency.

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 reactions.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.H11:section a through f - 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.

Manufacturer Narrative

1871, 2558, 2119 = "nl".

Event Description

Per additional information received, the patient has experienced nocturia, urinary leakage, fatigue, bacterial vaginosis (bacterial infection), chest pain, hemorrhoids, vaginal hematoma, incomplete bladder emptying, back pain, unspecified device complication, pyuria, urosepsis, unspecified symptoms associated with female organs, vaginitis, smelly vaginal discharge, residual urine, hernia, hazy urine appearance, nitrites, leukocytes, white blood cells, crystals, bacteria, red blood cells and protein in urine, cystotomy, fibrosis, thinned bladder wall, blood loss, pelvic organ prolapse, difficulty postponing urination, bladder trabeculations, vaginal area bulge, urinary urgency, poor urinary control, failure of implant, pelvic muscle wasting, lack of coordination, unstable bladder contractions, constipation, vaginal infection, hole in bladder, anxiety, scarring, mesh in bladder wall, right kidney stone, hematuria, foreign body in patient (surgical clips), hyperplastic polyp, vaginal discharge, urinary retention, vaginal extrusion, inflammation, renal calcifications, pelvic pain, caruncle, swelling, non-surgical and additional surgical intervention.

Manufacturer Narrative

1987 = "l", 2597, 2123 = "nl".

Event Description

Per additional information received, the patient has experienced, mesh in wall of bladder, mixed urinary incontinence, urge urinary incontinence, ball of mesh on left side, palpable sling, exposure of mesh, up to urinate at night, urinary incontinence, stanguria, abnormal urine, complication due to genitourinary device, cystotomy (organ perforation), small hole in bladder, fibrotic mesh, refractory urge incontinence, recurrence, infection, unspecified urinary problems, dyspareunia, neck pain, non-obstructing right calyceal stone, nitrates in urine, bloody vaginal discharge, difficulty having bowel movements, urinary bladder, urethra calcifications, calcification deep in right pelvis, and caruncle.

Event Description

Per additional information received on 11oct2021, the patient has experienced mesh erosion, pain, extrusion, infections, urinary problems, dyspareunia, stress urinary incontinence, fatigue, osteoporosis, dysuria, cystitis, bacterial vaginosis, chest pain, urinary tract infection, hemorrhoids, cystocele, vaginal hematoma, incomplete bladder emptying, chronic back pain, rectocele, prolapse, vaginitis, urge incontinence, voiding dysfunction, bladder injury, vaginal discharge, urinary retention, recurrent vaginal and bladder infections, difficulty in having the bowel movements, pelvic pain, swelling and required additional surgical and non-surgical interventions.

Manufacturer Narrative

1800, 3167, 3274 ="nl" correction: a4, g1.

• 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 Contact: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 5094580
• MDR Text Key: 319255307
• Report Number: 1018233-2010-00124
• 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
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/02/2013,10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2015
• 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 Model Number: 486010
• Device Catalogue Number: 486101
• Device Lot Number: CVRI0039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/02/2013
• Distributor Facility Aware Date: 10/24/2013
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/02/2013
• Date Manufacturer Received: 10/11/2021
• Date Device Manufactured: 09/26/2007
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Race: White