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 Micturition Urgency (1871); Incontinence (1928); 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, urinary problems, bowel problems, recurrence, dyspareunia (painful sexual intercourse), vaginal scarring, wound abscess, nausea, suprapubic wound hematoma, suprapubic tenderness and pressure, right groin pain, urinary incontinence, pelvic pain, urinary retention, urinary urgency, overactive bladder dysfunction, urethral obstruction, bleeding, chest pain, retractable urge urinary incontinence, nocturia, vaginal vault prolapse, cystocele, rectocele, enterocele and urinary frequency.

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 3.Qty 2- pelvilace biourethral support system 2 needle introducers, 1 disposable handle, 4 tissue connectors, 1.5cm x 50cm porcine accellular collagen matrix sling; qty 1- pelvilace to biourethral support system needle and implant hook needle 50cm.

• 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 blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 4469971
• MDR Text Key: 15317723
• Report Number: 1018233-2015-00024
• 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
• Report Date: 10/20/2014

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: 10/20/2014
• Initial Date FDA Received: 01/30/2015
• 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: 46 YR