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

Catalog Number 486201

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

Patient Problems Pain (1994); Injury (2348); Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

May 2018 bimonthly asr report.(b)(4).The total number of events for product classification code otp is 7.Qty 2- avaulta plus biosynthetic support system.Qty 1- avaulta plus biosynthetic support system - anterior, sterile.Qty 2- avaulta plus biosynthetic support system- posterior, sterile.Qty 2- avaulta solo biosynthetic support system- anterior, sterile.The information provided by bard 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 bard.

Event Description

May 2018 bimonthly asr report.

Event Description

N/a.

Manufacturer Narrative

Exemption (b)(4).Original reporting time frame (b)(6)2018 through (b)(6)2014.

Manufacturer Narrative

Exemption e2013025.Original reporting time frame (b)(6) 2018.Attachment: [1164275 e2013025 nov 2018 quarterly supp for may 2018 bimonthly otp.Xlsx].

Event Description

N/a.

• Brand Name: AVAULTA PLUS® BIOSYNTHETIC SUPPORT SYSTEM - POSTERIOR
• Type of Device: AVAULTA PLUS® BIOSYNTHETIC SUPPORT SYSTEM - POSTERIOR
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7534584
• MDR Text Key: 108932408
• Report Number: 1018233-2018-01792
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K082571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/15/2018

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: No Information
• Device Expiration Date: 07/31/2008
• Device Catalogue Number: 486201
• Device Lot Number: CVRH0024
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/07/2018
• Initial Date FDA Received: 05/22/2018
• Supplement Dates Manufacturer Received: 03/07/2018; 03/07/2018
• Supplement Dates FDA Received: 07/30/2018; 11/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention