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 Wound Dehiscence (1154); Unspecified Infection (1930); Hernia (2240); No Code Available (3191)

Event Date 06/08/2020

Event Type  Injury  

Manufacturer Narrative

Title: a low incidence of perineal hernia when using a biological mesh after extralevator abdominoperineal excision with or without pelvic exenteration or distal sacral resection in locally advanced rectal cancer patients source techniques in coloproctology, volume 24, 2020 (855¿861) date of publication online: 8 june 2020. (b)(4). If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed, the study aimed to evaluate the outcome of the use of a biological mesh after pelvic reconstruction in patients with advanced rectal cancer. A total of 35 patients were included in the study and all had pelvic floor reconstruction with mesh. Eighteen patients had minor to major would dehiscence, for which treatment was conservative in 8 cases. One patient received antibiotic treatment. A wound dehiscence grade 3 occurred in 9 patients, 5 patients needed vac therapy and the other four patients required reoperation with the use of petal flap in 2 cases. One patient had deep wound infection requiring permacol removal, and perineal hernia. A perineal hernia occurred in three patients and underwent correction of hernia.

• 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: 10435224
• MDR Text Key: 203865049
• Report Number: 9617613-2020-00070
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l

Reporter Occupation

• Type of Report: Initial
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• 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?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/04/2020
• 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: 08/20/2020 Patient Sequence Number: 1