MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH TSL - PERMACOL¿ MESH, SURGICAL

Model Number UNKNOWN PERMACOL PRODUCT

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Abscess (1690); Cellulitis (1768); Necrosis (1971)

Event Date 02/25/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4). Title a retrospective, italian multicenter study of complex abdominal wall defect repair with a permacol biological mesh source scientific reports, volume 10, 2020(1-8) date of publication: 25feb 2020. If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature case study about the efficacy of a cross-linked, acellular porcine dermal collagen matrix implant mesh for complex abdominal wall defect (cawd) repair between january 2010 and may 2016 which included 60 patients, the following outcomes were reported: 21 surgical site occurrence (sso) at 30 postoperative days; and (2) recurrence rate at 1-year and 2-years follow-up. Surgical site occurrence was defined the presence of one or more of the following features: 14 wound dehiscence, 1 skin/fat necrosis, 1 cellulitis/abscess, hematoma, 5 seroma and/or enterocutaneous fistula. One patient with minor wound dehiscence had the mesh removed after transcutaneous migration of the implant. It was reported that this patient¿s body did not incorporate the mesh, but rather created a thick fibrotic layer without a hernia defect; the mesh was rejected a little at time, until the surgeon decided to remove it.

• Brand Name: MESH TSL - PERMACOL¿
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer (Section G): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 9914633
• MDR Text Key: 191409416
• Report Number: 9615742-2020-00766
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• 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?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/17/2020
• 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: 04/02/2020 Patient Sequence Number: 1