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 Erosion (1750); Scar Tissue (2060); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Per direction by fda in an email dated june 26, 2019, an emdr is being filed to submit new information obtained prior to a letter received on may 15, 2019, regarding the revocation of the asr for exemption e2013025.It was agreed upon with the fda that the date of awareness would be the date of the email received, which is june 26, 2019.(b)(6), july 8, 2019.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

The patient's attorney alleged a deficiency against the device.Per additional information received, the patient has experienced erosion, urinary problems, bowel problems and vaginal scarring.Reason for report: revocation of asr, report id number: (b)(4), corresponding exemption number: e2013025.

• 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: angela robinson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 8768975
• MDR Text Key: 150542638
• Report Number: 1018233-2019-03703
• 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
• Report Date: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2010
• Device Catalogue Number: 486101
• Device Lot Number: CVSJ0009
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 10 MO
• Event Location: Hospital
• Date Manufacturer Received: 06/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2009
• 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: 50 YR
• Patient Weight: 104