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 Erosion (1750); Incontinence (1928); Internal Organ Perforation (1987)

Event Type  Injury  

Event Description

The patient's attorney alleged a deficiency against the device.Per additional information received, the patient has experienced vomiting, blood loss, urinary tract infection, discomfort, abdominal pain, dysuria, frequency, urinary pain, spasm, decreased output, stress urinary incontinence, pain, vaginal drainage, scant vaginal bleeding, failed mesh with implant, erosion, extrusion, infection, unspecified urinary problems, unspecified bowel problems, organ perforation, recurrence, dyspareunia, and vaginal scarring which required additional surgical and non-surgical intervention.

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.(b)(4).

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: 4641616
• MDR Text Key: 5595571
• Report Number: 1018233-2015-00086
• 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
• Report Date: 07/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 04/30/2010
• Device Catalogue Number: 482150
• Device Lot Number: CVSA0009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: 4 MO
• Event Location: Hospital
• Date Manufacturer Received: 01/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2008
• 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: 54 YR
• Patient Weight: 64