MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PELVILACE® TO TRANS-OBTURATOR BIOURETHRAL SUPPORT SYSTEM

Catalog Number 482151

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

Patient Problems Erosion (1750); Injury (2348); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The total number of events for product classification code pag is 5.Qty 1- pelvilace biourethral support system.Qty 1- pelvilace biourethral support system 2 needle introducers, 1 disposable handle, 4 tissue connectors, 1.5cm x 50cm porcine accellular collagen matrix sling.Qty 1- pelvilace to biourethral support system.Qty 2- pelvilace to biourethral support system needle and implant hook needle 50cm.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 returned.

Event Description

February 2018 quarterly asr report.

Manufacturer Narrative

Exemption e2013025 original reporting time frame: november 1, 2017 through january 31, 2018 e2013025.

Manufacturer Narrative

Exemption (b)(4).Original reporting time frame: (b)(6)2017 through (b)(6)2018.

Event Description

N/a.

• Brand Name: PELVILACE® TO TRANS-OBTURATOR BIOURETHRAL SUPPORT SYSTEM
• Type of Device: PELVILACE® TO TRANS-OBTURATOR BIOURETHRAL SUPPORT SYSTEM
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7272611
• MDR Text Key: 100125564
• Report Number: 1018233-2018-00455
• Device Sequence Number: 1
• Product Code: PAG
• Combination Product (y/n): N
• PMA/PMN Number: K042949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 10/31/2009
• Device Catalogue Number: 482151
• Device Lot Number: CVRB0019
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/22/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention