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

Catalog Number 486020

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

Patient Problems Arthritis (1723); Erosion (1750); Pain (1994); Anxiety (2328); Discomfort (2330); Depression (2361); Prolapse (2475); Urinary Incontinence (4572); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

The patient's attorney alleged a deficiency against the device.Additional information has been requested, but not yet received.

Manufacturer Narrative

No sample received.

Event Description

Per additional information received via medical records on 21dec2022, the patient has experienced mesh erosion, dyspareunia, vaginal and abdominal pain and urinary problems, vaginal vault prolapse, urinary incontinence, mixed incontinence, arthritis, anxiety, depression, cystocele, rectocele and required additional surgical and non-surgical interventions.

Manufacturer Narrative

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 POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM
• Type of Device: AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 15396568
• MDR Text Key: 299662399
• Report Number: 1018233-2022-90029
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 486020
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Date Manufacturer Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM; TVT SECUR
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 77 KG