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

Catalog Number 482152

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

Patient Problems Erosion (1750); Pain (1994); Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

January 2017 bimonthly asr report.(b)(4).The total number of events for product classification code pag is 22.Qty 15-pelvilace biourethral support system 2 needle introducers, 1 disposable handle, 4 tissue connectors, 1.5cm x 50cm porcine acellular collagen matrix sling.Qty 2- pelvilace to biourethral support system needle and implant halo needle 50cm.Qty 5- 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

January 2017 bimonthly asr report.

Manufacturer Narrative

(b)(4).Original reporting time frame november 1, 2016 to december 31, 2016 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).

• Brand Name: PELVILACE® TO TRANS-OBTURATOR BIOURETHRAL SUPPORT SYSTEM WITH HALO NEEDLE
• Type of Device: PELVILACE® TO TRANS-OBTURATOR BIOURETHRAL SUPPORT SYSTEM WITH HALO NEEDLE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; unit 1; covington GA 30014
• Manufacturer (Section G): TISSUE SCIENCE LABORATORIES -3004086170; astley lane industrial estate; unit 1; swillington, leeds LS26 8XT; UK LS26 8XT
• Manufacturer Contact: angela robinson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6248876
• MDR Text Key: 65114607
• Report Number: 1018233-2017-00090
• 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
• Report Date: 08/30/2017

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: 03/31/2010
• Device Catalogue Number: 482152
• Device Lot Number: CVRH0001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2016
• Initial Date FDA Received: 01/13/2017
• Supplement Dates Manufacturer Received: Not provided; 12/01/2016
• Supplement Dates FDA Received: 02/20/2017; 08/30/2017
• 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