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

Model Number P151520

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

Patient Problems Abscess (1690); Adhesion(s) (1695); Purulent Discharge (1812); Fistula (1862); Hematoma (1884); Unspecified Infection (1930); Necrosis (1971); Perforation (2001); Discharge (2225); Hernia (2240); Peritonitis (2252); Injury (2348); Impaired Healing (2378); Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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 hernia. It was reported that after implant, the patient experienced excision of prior incisional hernia mesh, recurrent incisional hernia repaired with new mesh. There was stool coming out from the hernia repair incision confirmed colonic perforation and fecal contamination around the hernia repair site, significant infection of abdominal wall, infected hematoma in lower abdomen, bowels were adhered, there were several pockets of abscesses, lysis of adhesions, chronic abscess with pus in left upper quadrant, debridement of abdominal wall, infected soft tissue and abscess, there was some necrosis in the area, there was presence of the mesh in this location caused chronic infection which did not allow the wound to heal. Post-operative patient treatment included additional surgery.

• 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: 8458070
• MDR Text Key: 140081533
• Report Number: 9617613-2019-00024
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/30/2019
• Device Model Number: P151520
• Device Catalogue Number: P151520
• Device Lot Number: AOG0663
• 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: 01/06/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 07/29/2014
• 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: 03/27/2019 Patient Sequence Number: 1