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

Model Number UNKNOWN PERMACOL PRODUCT

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

Patient Problems Fistula (1862); Scarring (2061); Hernia (2240); Injury (2348)

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 an incisional hernia.It was reported that after the implant, the patient experienced recurrence, scarring, and enterocutaneous fistula.Post-operative patient treatment included exploratory laparotomy, closure of enterocutaneous fistula, small bowel resection with anastomosis, left and right rectus abdominis muscle flaps rotated to the trunk, removal of fistula tract, removal of scar to abdomen, and debridement of abdominal wall.

• 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: 9711156
• MDR Text Key: 179547739
• Report Number: 9617613-2020-00026
• Device Sequence Number: 1
• Product Code: FTM
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/14/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PERMACOL PRODUCT
• Device Catalogue Number: UNKNOWN PERMACOL PRODUCT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/22/2019
• Initial Date FDA Received: 02/14/2020
• 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