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 Adhesion(s) (1695); Incontinence (1928); Pain (1994)

Event Type  Injury  

Event Description

It was reported by the patient's attorney that as a result of having the product implanted, the patient has experienced injury, pain, disability and impairment.Per additional information received, the patient has experienced unspecified recurrence, unspecified urinary problems, adhesions, cystocele, recurrent vaginal pain, and urinary incontinence.

Manufacturer Narrative

The sample was not returned.A lot number was provided; however, the number was determined to be invalid so a device history record review could not be performed.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.(b)(4).

Manufacturer Narrative

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

Manufacturer Narrative

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

• 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: christy lewis ; 8195 industrial boulevard; covington, GA 30014 ; 7707846100
• MDR Report Key: 4130175
• MDR Text Key: 4940827
• Report Number: 1018233-2014-00243
• 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
• Report Date: 07/01/2014

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: 07/01/2014
• Initial Date FDA Received: 09/30/2014
• Supplement Dates Manufacturer Received: 07/01/2014; 07/01/2014
• Supplement Dates FDA Received: 12/21/2014; 03/30/2015
• 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: 69 YR
• Patient Weight: 64