MAUDE Adverse Event Report: TISSUE SCIENCE LABORATORIES PELVILACE TO TRANS-OBTURATOR BIOURETHRAL SUPPORT SYSTEM WITH HOOK NEEDLE

Catalog Number 482151

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

Patient Problems Abdominal Pain (1685); Urinary Tract Infection (2120); Hernia (2240)

Event Type  Injury  

Event Description

The patient's attorney alleged a deficiency against the device.Per additional information received, the patient has experienced persistent postoperative abdominal pain, chronic pelvic pain, vaginal discharge, vaginal cuff tenderness, cuff cellulitis, umbilical hernia, right ovarian cyst, urinary tract infection, laparoscopic exploration with lysis of liver adhesions, appendectomy, right salpingo-oophorectomy, repair of incarcerated ventral hernia, recurrence, dyspareunia, vaginal scarring and has undergone additional surgical and non-surgical treatment.

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 adverse events: potential complications associated with the proper implantation of the pelvilace to system may include, but are not limited to: - postoperative hematoma, which may occur following the implant procedure.- 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.- transitory irritation at the operative wound site, which may elicit a foreign body response that leads to inflammation, infection, or erosion at the implant site.(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.Exemption (b)(4).The total number of events for product classification code pag is 5.Qty (b)(4)- pelvilace biourethral support system, (b)(4) needle introducers, (b)(4) disposable handle, (b)(4) tissue connectors, 1.5cm x 50cm porcine acellular collagen matrix sling.Qty (b)(4)- pelvilace to biourethral support system needle and implant halo needle 50cm qty (b)(4) pelvilace to biourethral support system needle and implant hook needle 50cm.

• Brand Name: PELVILACE TO TRANS-OBTURATOR BIOURETHRAL SUPPORT SYSTEM WITH HOOK NEEDLE
• Type of Device: PELVILACE TO TRANS-OBTURATOR BIOURETHRAL SUPPORT SYSTEM WITH HOOK NEEDLE
• 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: 4806098
• MDR Text Key: 5930197
• Report Number: 1018233-2015-00188
• 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
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 03/31/2015

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 Catalogue Number: 482151
• 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: 03/31/2015
• Initial Date FDA Received: 05/29/2015
• 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: 45 YR
• Patient Weight: 88