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

Catalog Number 482152

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

Patient Problems Erosion (1750); Incontinence (1928)

Event Type  Injury  

Event Description

The patient's attorney alleged a deficiency against the device.Per additional information received, the patient has experienced pain, erosion, urinary problems and dyspareunia.

Manufacturer Narrative

(b)(4).The total number of events for product classification code pag is (b)(4).(b)(4) - pelvilace biourethral support system 2 needle introducers, (b)(4) disposable handle, (b)(4) tissue connectors, 1.5cm x 50cm porcine accellular collagen matrix sling (b)(4) - pelvilace to biourethral support system; (b)(4) - pelvilace to biourethral support system needle and implant halo needle 50cm; (b)(4) - pelvilace to biourethral support system needle and implant hook needle 50cm.The sample was not returned.The finished product met all specifications prior to being released for general distribution.The instructions for use which accompanies all devices currently addresses potential risks associated with surgically implanted materials.The instructions for use states in the adverse events potential complications associated with the proper implantation of the pelvilace[?] to system may include, but are not limited to: -postoperative hematoma, which may occur following the implant procedure.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; -transitory irritation at the operative wound site, which may elicit a foreign body response that leads to inflammation, infection, or erosion at the implant site.(b)(4).

Manufacturer Narrative

Exemption no: e2013025.Original reporting time frame from (b)(6) 2014 to (b)(6) 2014.

Manufacturer Narrative

Exemption number e2013025.Original reporting time frame (b)(6) 2014 ¿ (b)(6) 2014.

Manufacturer Narrative

Original reporting time frame (b)(6) 2014 to (b)(6) 2014.

Manufacturer Narrative

Exemption no.E2013025.Original reporting time frame (b)(6) 2014 to (b)(6) 2014.

Manufacturer Narrative

Exemption no.E2013025.Original reporting time frame (b)(6) 2014 to (b)(6) 2014.

Manufacturer Narrative

Exemption no.E2013025.Original reporting time frame (b)(6) 2014 to (b)(6) 2014.

Manufacturer Narrative

Exemption no.E2013025.Original reporting time frame may 1, 2014 to june 30, 2014.

Manufacturer Narrative

Exemption no.E2013025.Original reporting time frame may 1, 2014 to june 30, 2014.

Manufacturer Narrative

Exemption no.E2013025.Original reporting time frame may 1, 2014 to june 30, 2014.

• Brand Name: PELVILACE TO BIOURETHRAL SUPPORT SYSTEM WITH HALO NEEDLE
• 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: 3968449
• MDR Text Key: 4629567
• Report Number: 1018233-2014-00190
• 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,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2013
• Device Catalogue Number: 482152
• Device Lot Number: BMVD0009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: 11 MO
• Event Location: Hospital
• Date Manufacturer Received: 05/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2011
• 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: 51 YR