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

Model Number P101010

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Abscess (1690); Adhesion(s) (1695); Erosion (1750); Hematoma (1884); Unspecified Infection (1930); Pain (1994); Seroma (2069); Hernia (2240); Discomfort (2330); Injury (2348); Obstruction/Occlusion (2422); Fluid Discharge (2686); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This information was received as a part of an extensive mesh litigation submission to medtronic. The fda was notified of this large complaint receipt. Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target. 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 a parastomal hernia. It was reported that after implant, the patient experienced pain, adhesions, abscess, bowel obstruction, erosion, infection, seroma and recurrence. Post-operative patient treatment included revision surgery, aspiration of seroma, lysis of adhesions and recurrence repair.

Event Description

The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome. Product was used for therapeutic treatment. Pre-operative and post-operative diagnosis: incarcerated obstructing parastomal hernia. Procedure: reduction of the hernia via parastomal approach with mesh repair of the defect. Events: the patient had surgical revisions, paid, adhesions, bowl obstruction, erosion, infections, seroma, and recurrence.

• Brand Name: MESH TSL - PERMACOL¿
• Type of Device: MESH, SURGICAL
• 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: 7027593
• MDR Text Key: 262739461
• Report Number: 9617613-2017-05136
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 10884523000108
• UDI-Public: 10884523000108
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992556
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/31/2012
• Device Model Number: P101010
• Device Catalogue Number: P101010
• Device Lot Number: 09B0808
• 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: 05/22/2019
• 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: Initial

Patient Treatment Data

Date Received: 11/14/2017 Patient Sequence Number: 1