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

Catalog Number 482150

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

Patient Problems Abdominal Pain (1685); Pain (1994); Injury (2348)

Event Type  Injury  

Event Description

The patient's attorney alleged a deficiency against the device.Per additional information received, the patient has experienced pain, lack of appetite, pressure, discomfort, abdominal pain, increased temperature greater than 100 degrees, nausea, weakness, anxiety and approximate blood loss of 300 ml.

Manufacturer Narrative

The sample was not returned.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use which accompanies all devices currently addresses potential risks associated with surgically implanted materials.The instructions for use states in the potential complications: complications associated with the proper implantation of the pelvilace biourethral support system may include, but are not limited to: postoperative hematoma.Temporary urinary retention, bladder outlet obstruction, and voiding difficulties associated with over-correction/too much tension placed on the implant.Perforations or lacerations of vessels, nerves, bladder or bowel, which may occur during needle passage.(b)(4).The total number of events for product classification code pag is 83.Qty 35- pelvilace biourethral support system 2 needle introducers, 1 disposable handle, 4 tissue connectors, 1.5cm x 50cm porcine acellular collagen matrix sling.Qty 4- pelvilace to biourethral support system.Qty 8- pelvilace to biourethral support system needle and implant halo needle 50cm.Qty 32- pelvilace to biourethral support system needle and implant hook needle 50cm.Qty 4- unknown bmd women's health product.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Original reporting time frame november 1, 2014 through january 31, 2015.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 november 1, 2014 to january 31, 2015.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 november 1, 2014 through january 31, 2015.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 no.(b)(4).Original reporting time frame (b)(4) 2014 through (b)(4) 2015.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 november 1, 2014 through january 31, 2015.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).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).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).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).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 (b)(4).Original reporting time frame november 1, 2014 through january 31, 2015.The information provided by bard represents all of the known information at this time.

• Brand Name: PELVILACE BIOURETHRAL SUPPORT SYSTEM
• Type of Device: PAG
• 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: 4555252
• MDR Text Key: 5456546
• Report Number: 1018233-2015-00057
• Device Sequence Number: 1
• Product Code: PAG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/15/2018

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: Health Professional
• Device Catalogue Number: 482150
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/13/2014
• Initial Date FDA Received: 02/27/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; Not provided; 10/13/2014; 10/13/2014; 10/13/2014; 10/13/2014; 09/21/2017
• Supplement Dates FDA Received: 05/29/2015; 11/30/2015; 02/24/2016; 01/20/2017; 05/22/2017; 07/24/2017; 08/30/2017; 09/22/2017; 11/16/2017; 11/15/2018
• 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
• Patient Age: 45 YR