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

Model Number UNKNOWN PERMACOL PRODUCT

Device Problems Migration or Expulsion of Device (1395); Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Purulent Discharge (1812); Erythema (1840); Fever (1858); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Swelling (2091); Hernia (2240); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Ascites (2596); Abdominal Distention (2601); Bowel Perforation (2668); 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 parastomal and ventral hernias. It was reported that after implant, the patient experienced recurrence, unhealed abdominal wound with infection, adhesions, small bowel obstruction, swelling, erythema, and abscess. Post-operative patient treatment included removal surgery, ventral hernia repaired with new mesh, multilayer closure with tissue rearrangement, incision and drainage of abdominal wall wound collection, incision and drainage of abscess, and small bowel resection.

• 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: 9210142
• MDR Text Key: 167576649
• Report Number: 9617613-2019-00173
• 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

• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: UNKNOWN PERMACOL PRODUCT
• Device Catalogue Number: UNKNOWN PERMACOL PRODUCT
• 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: 11/11/2019
• 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: 10/18/2019 Patient Sequence Number: 1