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

Catalog Number 486010

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

Patient Problems Itching Sensation (1943); Burning Sensation (2146); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

The patient¿s attorney alleged a deficiency against the device.Per additional information received, the patient has experienced vulvar burning and itching, urinary leakage, pessary use, grade two cystocele, vulvar yeast, urge incontinence, questionable retention, not emptying well, pad use, vulvitis, urinary frequency, urinary urgency, vulvar abscess and vaginal prolapse and required multiple surgical and nonsurgical interventions.

Manufacturer Narrative

Correction: f2.Per email received from the fda on 11dec2020, a correction is being submitted for f2 as the initial mdr report inadvertently included the manufacture report no.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 ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM
• Type of Device: AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9086350
• MDR Text Key: 162084815
• Report Number: 1018233-2019-05772
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 09/19/2019,01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 486010
• Device Lot Number: ZGJ00188
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/19/2019
• Distributor Facility Aware Date: 12/11/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/19/2019
• Date Manufacturer Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AVAULTA PLUS POSTERIORBIOSYNTHETIC SUPPORT; CONTIGEN SYRINGE
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 68