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

Catalog Number 482150

Device Problem Insufficient Information (3190)

Patient Problems Incontinence (1928); Scarring (2061); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The total number of events for product classification code pag is 60.Qty 46- pelvilace biourethral support system 2 needle introducers, 1 disposable handle, 4 tissue connectors, 1.5cm x 50cm porcine acellular collagen matrix sling.Qty 3- pelvilace to biourethral support system needle and implant halo needle 50cm.Qty 11- 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

Feb 2017 asr.

Manufacturer Narrative

(b)(4).Original reporting time frame (b)(6) 2016 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

(b)(4).Original reporting time frame (b)(6) 2016 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 november 1, 2016 through january 31, 2017.

Manufacturer Narrative

Exemption e2013025.Original reporting time frame november 1, 2016 through january 31, 2017.

Manufacturer Narrative

Exemption e2013025.Original reporting time frame november 1, 2016 through january 31, 2017.

• Brand Name: PELVILACE® BIOURETHRAL SUPPORT SYSTEM
• Type of Device: PELVILACE® BIOURETHRAL SUPPORT SYSTEM
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; unit 1; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; unit 1; covington GA 30014
• Manufacturer Contact: angela robinson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6335247
• MDR Text Key: 67599594
• Report Number: 1018233-2017-00462
• Device Sequence Number: 1
• Product Code: PAG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 06/30/2009
• Device Catalogue Number: 482150
• Device Lot Number: CVQK0002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention