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

Catalog Number 486101

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

Patient Problems Asthma (1726); Bacterial Infection (1735); Erosion (1750); Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Inflammation (1932); Muscle Weakness (1967); Pain (1994); Abnormal Vaginal Discharge (2123); Pressure Sores (2326); Anxiety (2328); Depression (2361); Osteopenia/ Osteoporosis (2651); Intermenstrual Bleeding (2665); Skin Inflammation/ Irritation (4545); Urinary Incontinence (4572)

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." (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 and impairment.

Event Description

Per additional information received on 24nov2021, the patient has experienced pelvic pain, mesh erosion, chronic vulvitis, atrophic vaginitis, stress urinary incontinence, vaginal irritation, suspected urinary tract injury, dry mouth, dry vaginal mucosa and impaired concentration, muscles aches, muscle weakness, arthralgias, joint pain, back pain, vaginal cuff palpated, vaginal lesion, mild intermittent asthma, mild depression, hypothyroidism, multiple thyroid nodules, aspirin intolerance, dyspnea, allergic rhinitis, postmenopausal bleeding, granulation tissue with acute and chronic inflammation, persistent vaginal spotting, anxiety, trigeminal neuralgia, hypercholesterolemia, osteopenia, vitamin d deficiency, bloody discharge, sores in vaginal mucosa, pruritis of vulva, bacterial infections, abnormal vaginal bleeding, ulcerative colitis, diverticulitis, fibroids, hypertension, bladder falling sensation and required additional surgical and non-surgical interventions.

Manufacturer Narrative

1750, 1932, 1735="l".1908, 1928, 1941, 2145="nl".H11:section a through f - the information provided by bd 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 bd.

• 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: 12205127
• MDR Text Key: 262895947
• Report Number: 1018233-2021-80051
• 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,Followup
• Report Date: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2008
• Device Catalogue Number: 486101
• Device Lot Number: CVRI0022
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 2 MO
• Event Location: Hospital
• Date Manufacturer Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2007
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White