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

Catalog Number 482151

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

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The total number of events for product classification code pag is (b)(4).Qty 5- pelvilace biourethral support system 2 needle introducers, 1 disposable handle, 4 tissue connectors, 1.5cm x 50cm porcine acellular collagen matrix sling.Qty 1- pelvilace to biourethral support system, qty 2- pelvilace to biourethral support system needle and implant halo needle 50cm, qty 10- 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

(b)(6) 2017 asr.

Manufacturer Narrative

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

Manufacturer Narrative

Exemption e2013025.Original reporting time frame (b)(6) 2017 through (b)(6) 2017.

Manufacturer Narrative

Exemption e2013025.Original reporting time frame january 1, 2017 through february 28, 2017.

• Brand Name: PELVILACE® TO TRANS-OBTURATOR BIOURETHRAL SUPPORT SYSTEM WITH HOOK NEEDLE
• Type of Device: PELVILACE® TO TRANS-OBTURATOR BIOURETHRAL SUPPORT SYSTEM WITH HOOK NEEDLE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; unit 1; covington GA 30014
• MDR Report Key: 6405959
• MDR Text Key: 69994465
• Report Number: 1018233-2017-01106
• 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,Followup
• Report Date: 07/27/2018

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: 10/31/2008
• Device Catalogue Number: 482151
• Device Lot Number: CVQH0005
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/26/2017
• Initial Date FDA Received: 03/15/2017
• Supplement Dates Manufacturer Received: 01/26/2017; 01/26/2017; 01/26/2017
• Supplement Dates FDA Received: 09/22/2017; 11/16/2017; 07/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention