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

Model Number UNK PELVICOL

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

Patient Problems Erosion (1750); Unspecified Infection (1930); Pain (1994); Scarring (2061); Urinary Frequency (2275); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Medtronic complaint report: (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 resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.Reason for mesh implantation: stress urinary incontinence and pelvic relaxation.Procedure (s) performed: endoscopic bladder neck suspension, pelvilace sling, anterior and posterior mesh revision surgery details: reason for surgery: voiding dysfunction following pubovaginal sling, urinary urgency, frequency and bladder pain procedure (s) performed: transvaginal urethrolysis with takedown of pubovaginal sling complications post implant: voiding dysfunction following pubovaginal sling, urinary urgency, frequency and bladder pain, pain, erosion, infection, dyspareunia, recurrence, neuromuscular problems and vaginal scarring.

• 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: 7399043
• MDR Text Key: 104433335
• Report Number: 9617613-2018-00022
• 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: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK PELVICOL
• Device Catalogue Number: UNK PELVICOL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/17/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR