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 Muscle Spasm(s) (1966); Cramp(s) (2193); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

January 2018 bimonthly asr.Exemption e2013025.The total number of events for product classification code otp is 7.Qty 1- avaulta plus biosynthetic support system.Qty 3- avaulta plus biosynthetic support system- posterior, sterile.Qty 2- avaulta solo biosynthetic support system- anterior, sterile.Qty 1- avaulta solo biosynthetic support system- posterior, 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.Sample not received.

Event Description

January 2018 bimonthly asr.

Manufacturer Narrative

Exemption e2013025.Original reporting time frame: november 1, 2017 through december 31, 2017.

Event Description

N/a.

Manufacturer Narrative

Exemption (b)(4).Original reporting time frame:(b)(6)2017 through (b)(6)2017.

• 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: 7205701
• MDR Text Key: 97757414
• Report Number: 1018233-2018-00174
• 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: 07/30/2018

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: 03/31/2011
• Device Catalogue Number: 486201
• Device Lot Number: BMUC0018
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/30/2017
• Initial Date FDA Received: 01/19/2018
• Supplement Dates Manufacturer Received: 10/30/2017; 10/30/2017
• Supplement Dates FDA Received: 02/22/2018; 07/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention