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

Model Number 482027

Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Erosion (1750); Calcium Deposits/Calcification (1758); Low Blood Pressure/ Hypotension (1914); Incontinence (1928); Pain (1994); Sepsis (2067); Injury (2348); Obstruction/Occlusion (2422); Blood Loss (2597); Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

Medtronic complaint report: (b)(4). Additional information: exemption number: e2013003. If information is provided in the future, a supplemental report will be issued.

Event Description

Per additional information received, the patient has experienced kidney stone (calcification), low blood pressure/hypotension, elevated temperature, obstruction, sepsis, milky white urine, extrusion, erosion, stress urinary incontinence, mesh exposure, foreign body in patient, blood loss, urinary leakage, pain, additional surgical and nonsurgical interventions.

Manufacturer Narrative

Medtronic complaint number: (b)(4). A good faith effort will be made to obtain the applicable information relevant to the report. 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. Procedure was a cystoscopy with sling bladder suspension for stress incontinence. On (b)(6) 2015 removal of exposed vaginal mesh, harvest of rectus fascia, placement of rectus fascia sling and cystoscopy performed due to a history of tvt mesh extrusion/erosion into the bladder and stress urinary incontinence.

• 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: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6758805
• MDR Text Key: 248637071
• Report Number: 9617613-2017-05109
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: MC
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 482027
• Device Catalogue Number: 482027
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/07/2017
• 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: Initial

Patient Treatment Data

Date Received: 08/01/2017 Patient Sequence Number: 1