MAUDE Adverse Event Report: TISSUE SCIENCE LABORATORIES MESH TSL - PELVICOL¿ MESH, SURGICAL, POLYMERIC

Model Number 482412

Device Problems Loss of or Failure to Bond (1068); Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Fistula (1862); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Scarring (2061); Discomfort (2330); Injury (2348); Prolapse (2475); Blood Loss (2597); Fibrosis (3167); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This event was previously submitted on a summary report (e2013038b).  subsequently, medtronic has received additional information which is being submitted via this 3500a. Exemption number: (b)(4). If information is provided in the future, a supplemental report will be issued.

Event Description

The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of pelvic organ prolapse, urinary incontinence. It was reported that after implant, the patient experienced blood loss, pain, discomfort, erosion, infection, fistulae, scarring, cystocele, enterocele(prolapse), rejected vaginal graft, unspecified mesh complications, unspecified urinary problems, unspecified bowel problems, recurrence, dyspareunia, unspecified neuromuscular problems, postgraft pain, fibrotic nodule in segment of graft, graft with necrotic material, paravaginal defect, mass effect, banding, and required nonsurgical and additional surgical interventions. The device had been used with tension-free vaginal tape ethicon/ johnson + johnson.

• Brand Name: MESH TSL - PELVICOL¿
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): TISSUE SCIENCE LABORATORIES; victoria house, victoria road; aldershot, hampshire GU11 1EJ; GB GU11 1EJ
• Manufacturer (Section G): TISSUE SCIENCE LABORATORIES; victoria house, victoria road; aldershot, hampshire GU11 1EJ; GB GU11 1EJ
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 8649770
• MDR Text Key: 146364071
• Report Number: 9617613-2019-00067
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (Y/N): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: OTHER

Reporter Occupation

• Type of Report: Initial
• Report Date: 05/29/2019

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 05/29/2019
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 03/19/2005
• Device MODEL Number: 482412
• Device Catalogue Number: 482412
• Device LOT Number: 03B02
• Was Device Available For Evaluation?: No

Is The Reporter A Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/15/2019
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient TREATMENT DATA

Date Received: 05/29/2019 Patient Sequence Number: 1