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); Pain (1994); Prolapse (2475)

Event Type  Injury  

Event Description

Per additional information received, the patient has experienced prolapse recurrence, constipation, urethral hypermobility, postmenopausal atrophic vaginitis, rectocele, cystocele, enterocele, atypical urothelial cells, sling that had migrated to the bladder neck, pain, erosion, extrusion, urinary problems, dyspareunia, emotional distress, and a loss of consortium.

Manufacturer Narrative

(b)(4).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 adverse events: potential 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).

Manufacturer Narrative

(b)(4).Initial reporting period: (b)(4) 2013 - (b)(4) 2013.

Manufacturer Narrative

(b)(4).Original reporting time frame november 1, 2013 ¿ december 31, 2013.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.

Manufacturer Narrative

(b)(4).Original reporting time frame november 1, 2013 through december 31, 2013.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.

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.

Manufacturer Narrative

Exemption no.(b)(4).Original reporting time frame november 1, 2013 through december 31, 2013.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; unit 1, astley lane industrial; swillington, leeds, LS26 8XT; UK LS26 8XT
• Manufacturer (Section G): TISSUE SCIENCE LABORATORIES 3004086170; unit 1, astley lane industrial; swillington, leeds, LS26 8XT; UK LS26 8XT
• Manufacturer Contact: angela robinson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 3596041
• MDR Text Key: 4092135
• Report Number: 1018233-2014-00020
• 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,other
• Reporter Occupation: Attorney
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/11/2019

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: 02/29/2012
• Device Catalogue Number: 482150
• Device Lot Number: CVTH0026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: 15 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/06/2013
• Initial Date FDA Received: 01/28/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 11/06/2013; 11/06/2013
• Supplement Dates FDA Received: 03/31/2014; 01/28/2016; 02/24/2016; 07/27/2018; 01/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2009
• 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: 64 YR