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 Problems Scarring (2061); Blood Loss (2597); Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

The july 2017 bimonthly asr report exemption (b)(4).The total number of events for product classification code pag is 12.Qty 10- 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 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

The july 2017 bimonthly asr report.

Manufacturer Narrative

Exemption e2013025.Original reporting time frame may 1, 2017 through june 30, 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
• 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: 6711221
• MDR Text Key: 79960892
• Report Number: 1018233-2017-03726
• 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
• Report Date: 09/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2017
• 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: CVQG0033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/01/2017
• 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