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 Erosion (1750); Incontinence (1928); Urinary Frequency (2275)

Event Type  Injury  

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.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.Exemption (b)(4).The total number of events for product classification code pag is 1.Qty 1- pelvilace to biourethral support system needle and implant hook needle 50cm.

Event Description

It was reported in the patient's medical records that as a result of having the product implanted, the patient has experienced pain, infection, erosion of mesh, recurrence, bleeding, dyspareunia, urinary problems, neuromuscular problems, bowel problems, vaginal scarring, possible extrusion, fever of unclear etiology and was prescribed antibiotics, husband also complained of something cutting his penis during intercourse, mesh removed, suffered from dysuria and pelvic pain and was treated empirically for acute cystitis, continued to have dyspareunia which was felt likely to be due to post hysterectomy adhesions, bilateral groin pain, left thigh numbness and weakness, referred for physical therapy and after completing 15 sessions, reported complete elimination of her pain, recurrence of stress urinary incontinence, underwent a second sling placement on ((b)(6) 2012), stress urinary incontinence resolved after second implant; however, suffered from urinary tract infections, worsening urge incontinence, frequency and nocturia.Treated with vesicare and a series of bladder lavages for chronic interstitial cystitis and underwent interstim placement on ((b)(6) 2012) which improve her symptoms.

• 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 -3004086170; 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: 5391126
• MDR Text Key: 36824349
• Report Number: 1018233-2016-00040
• 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: 11/16/2015

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 Expiration Date: 04/30/2014
• Device Catalogue Number: 482150
• Device Lot Number: BMWC0013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: 1 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/16/2015
• Initial Date FDA Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2012
• 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: 44 YR
• Patient Weight: 83