MAUDE Adverse Event Report: TISSUE SCIENCE LABORATORIES PELVILACE BIOURETHRAL SUPPORT SYSTEM; PAG

Catalog Number 482150

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

Patient Problems Incontinence (1928); Scarring (2061)

Event Type  Injury  

Event Description

The patient's attorney alleged a deficiency against the device.Per additional information received, the patient has experienced recurrent stress urinary incontinence and scarring which required surgical intervention.

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 precautions: · the pelvilace biourethral support system is for single-patient use only and is to be implanted surgically.· do not use the pelvilace biourethral support system if the integrity of the packaging appears compromised.· the pelvilace biourethral support system pelvicol® implant should be hydrated or moist when the package is opened.Dehydrated or dry tissue should not be implanted.· postoperative retropubic bleeding may occur in some patients and must be controlled prior to patient release.· the pelvilace biourethral support system procedure requires diligent attention to anatomical structure and care to avoid puncture of large vessels, nerves, bladder, and bowel, during needle passage.· proper placement of the pelvilace biourethral support system at mid-urethra requires that the tissue lie flat with minimal or no tension under the urethra.· the pelvilace biourethral support system is intended as a single-use, disposable device.Do not resterilize any portion of the pelvilace biourethral support system.· patients should be advised that pregnancy following an pelvilace biourethral support system procedure may negatively affect the success of the previous procedure and incontinence may reoccur.· the safety and effectiveness of pelvilace biourethral support system has not been established for the treatment of stress urinary incontinence in males and children under the age of 18.Exemption (b)(4).The total number of events for product classification code pag is (b)(4).(b)(4)- pelvilace biourethral support system (b)(4) 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 hook needle 50cm.(b)(4)- unknown bmd women's health product.(b)(4).

Manufacturer Narrative

(b)(4).Original reporting time frame september 1, 2014 through october 31, 2014.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.

• Brand Name: PELVILACE BIOURETHRAL SUPPORT SYSTEM
• Type of Device: PAG
• Manufacturer (Section D): TISSUE SCIENCE LABORATORIES; 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: angela robinson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 4263021
• MDR Text Key: 5109450
• Report Number: 1018233-2014-00319
• 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
• Report Date: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2014
• 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
• Date Manufacturer Received: 08/04/2014
• 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: 58 YR