MAUDE Adverse Event Report: TISSUE SCIENCE LABORATORIES -3004086170 PELVILACE BIOURETHRAL SUPPORT SYSTEM

Catalog Number 482150

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

Patient Problems Unspecified Infection (1930); Pain (1994); Urinary Retention (2119)

Event Type  No Answer Provided  

Manufacturer Narrative

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 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 (b)(4).Pelvilace biourethral support system 2 needles introducers, (b)(4) disposable handle, (b)(4) tissue connectors, 1.5cm x 50cm porcine acellular collagen matrix sling.(b)(4) - pelvilace 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 received.

Event Description

The patient's attorney alleged a deficiency against the device.Per additional information received, the patient has experienced incomplete bladder emptying (urinary retention), pain, extrusion, infection, unspecified urinary problems, recurrence, bleeding and additional surgical intervention.

Manufacturer Narrative

The emdr was submitted in error.It was previously reported on the august 2015 quarterly asr.Arobinson 11/10/2015.

• Brand Name: PELVILACE BIOURETHRAL SUPPORT SYSTEM
• Type of Device: PELVILACE BIOURETHRAL SUPPORT SYSTEM
• Manufacturer (Section D): TISSUE SCIENCE LABORATORIES -3004086170; astley lane industrial estate; unit 1; swillington, leeds LS26 8XT; UK LS26 8XT
• Manufacturer (Section G): TISSUE SCIENCE LABORATORIES; astley lane industrial estate; unit 1; swillington, leeds LS26 8XT; UK LS26 8XT
• Manufacturer Contact: janna parks ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 5206777
• MDR Text Key: 30569422
• Report Number: 1018233-2015-00437
• 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
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 11/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2012
• Device Catalogue Number: 482150
• Device Lot Number: CVTH0026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: 12 MO
• Event Location: Hospital
• Date Manufacturer Received: 11/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2009
• 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: 54 YR