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

Catalog Number 486100

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

Patient Problems Bacterial Infection (1735); Micturition Urgency (1871); Low Blood Pressure/ Hypotension (1914); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Injury (2348); Disability (2371); Obstruction/Occlusion (2422); Prolapse (2475); Dyspareunia (4505); Urinary Incontinence (4572); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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, injury, disability, and impairment.

Event Description

As per additional information received via medical records on 10jan2024, the patient experienced urethral obstruction, mesh exposure, chronic pain, dyspareunia, apareunia, recurrent stress urinary incontinence, voiding dysfunction, pelvic floor dysfunction, vaginal scarring, emotional and psychological stress, urgency, mixed urinary incontinence, motion sickness, postoperative nausea and vomiting, cystocele, rectocele, hypotension or low blood pressure, recurrent or chronic vaginal or bladder infections, recurrent vaginal pain, urinary incontinence, urinary retention, leg pains at night, passing gas to urinate, bulge and pressure in the vaginal area, bacteriuria, stage 2 posterior wall prolapse, pelvic tension noted bilaterally, tenderness requiring additional surgical and non-surgical treatments.

Manufacturer Narrative

2061,1930 = "l".2422,1928,1871,1914,2119 = "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 SOLO® SYNTHETIC SUPPORT SYSTEM - ANTERIOR
• Type of Device: AVAULTA SOLO® SYNTHETIC 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: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 9278240
• MDR Text Key: 165025846
• Report Number: 1018233-2019-07022
• Device Sequence Number: 1
• Product Code: OTP
• UDI-Device Identifier: 00801741168024
• UDI-Public: (01)00801741168024
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092607
• 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: 02/02/2024

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: 08/31/2011
• Device Catalogue Number: 486100
• Device Lot Number: HUTH1292
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/18/2019
• Initial Date FDA Received: 11/05/2019
• Supplement Dates Manufacturer Received: 01/10/2024
• Supplement Dates FDA Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2009
• 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
• Treatment: ALIGN® TO URETHRAL SUPPORT SYSTEM - HALO
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 62 KG